55 Regulatory Affairs Manager jobs in Malaysia

Key Result Areas (Regulatory)

• Adherence to AZ and industry codes of conduct, ethics, PhAMA code & Good Regulatory Practices.
• Maintenance of product licenses to a high standard throughout current year, with zero negative impact to business objectives & financial targets.
• Develop & implement regulatory strategy for responsible therapeutic area to achieve rapid & high-quality approvals & facilitate rapid launch.
• Provide guidance and functional support to regulatory team member.
• Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders.
• Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs.
• Proactive cross-functional teamwork contributing to optimum business strategies.
• Manage legal (including contracts) & Patent-related matters.
• Manage regulatory vendors and suppliers according to AZ requirements where applicable.
• Act as Company Pharmacist and Poison A License holder for the company.
• As Provisional Registered Pharmacist (PRP) Preceptor for the company (if require).

Typical Accountabilities

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Regulatory Affairs.
• Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
• Report potential issues of non-compliance

Education, Qualifications, Skills and Experience

Essential

• Pharmacy or Scientific Degree or equivalent professional qualification in related field
• Minimal 5 years of experience in regulatory affairs area.

• Post-graduate qualification

Key Relationships to reach solutions

Internal

• Country Leadership Team
• Country Cross Functional Team (Quality Assurance, Commercial, Medical, Supply Chain, HR, Finance, Market Access/Tender, Corporate Communications)
• Manufacturing Site, GRAPSQA, Global Supply Chain
• Quality Functional Leadership Teams

External

• Regulatory bodies
• Pharmaceutical companies
• Distributors
• Local Trade Associations
• HCPs & KEEs

Date Posted

27-Ogo-2025

Closing Date

26-Sep-2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Biomed Global Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Regulatory Affairs Manager

Biomed Global Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Direct message the job poster from Biomed Global

Talent Management Specialist |Just your friendly neighborhood Recruiter | Career Match-Maker| I don't usually stalk Profiles, but when I do I…

Position: Regulatory Affair Manager

Industry: Healthcare/ Medical Device

Responsibilities

• Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
• Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
• Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
• Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
• Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
• Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
• Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
• Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
• Ensure compliance with advertisement and labeling regulations in each marketing territory.
• Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
• Plan and lead the implementation of internal RA audits on an annual basis.
• Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
• Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
• Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
• Support regulatory matters related to custom import requirements and documentation.
• Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.

Qualifications

• Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.

Required Skills

• Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
• Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
• Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers, effectively.
• In-depth knowledge and hands-on experience in medical device registration and regulatory compliance , particularly in Malaysia, Singapore, and Indonesia.
• Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
• Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
• Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
• Meticulous and detail-oriented, capable of working independently with minimal supervision.
• Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
• Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
• Pharmacist background with a valid license will be an added advantage.

Seniority level

• Seniority level Not Applicable

Employment type

• Employment type Full-time

Job function

• Job function Management, Legal, and Strategy/Planning
• Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Biomed Global by 2x

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Taman Tun Dr Ismail, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

Regulatory Affairs Senior Executive / Assistant Manager

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

Regulatory Affairs Senior Executive / Assistant Manager

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 day ago

Petaling Jaya, Selangor, Malaysia 3 days ago

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

Senior Regulatory Affairs Specialist, APAC

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 6 days ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 8 months ago

Petaling Jaya, Selangor, Malaysia 6 days ago

Senior Manager / Manager ( Regulatory Assurance and Advisory Services – Prudential Regulation)

Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago

Regulatory Compliance Manager, Markets and Securities Services - Malaysia

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 months ago

Assurance - Manager/Senior Manager (Regulatory Assurance and Advisory Services)

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 5 days ago

Senior Project Manager - Regulatory and Compliance

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 6 days ago

PBTB| Assistant Manager, Projects and Regulatory Assistant Manager, Financial and Regulatory Reporting M/F SR&T Project Manager, Regulatory & Financial Risk

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

Regulatory Affairs Associate ( 1 year contract)

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 5 days ago

Cluster Medical & Regulatory Affairs Lead

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

Manager_Markets Onboarding Regulatory Implementation

Bukit Jalil, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

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Brunel Federal Territory of Kuala Lumpur, Malaysia Direct message the job poster from Brunel Overview

APAC Life Sciences Expert (Pharma/Devices/Biotech) Lead and manage all regulatory activities for the company’s portfolio across SEA. This role ensures compliance with local and regional regulations, facilitates market access, and provides strategic regulatory guidance to support business objectives. Responsibilities

Develop and implement regulatory strategies to achieve timely approvals and market access across SEA countries. Ensure products comply with local, regional, and international regulations and monitor regulatory changes to provide proactive guidance to the business. Prepare, compile, and submit regulatory dossiers for product registration, renewals, and variations in SEA markets, coordinating with local distributors or partners as needed. Liaise with regulatory authorities to facilitate approvals and address any questions or deficiencies. Ensure compliance with post-market requirements, including vigilance, reporting, labeling, and quality system documentation, and support regulatory audits, inspections, and reporting requirements. Advise on regulatory implications of product changes, complaints, or recall. Collaborate closely with R&D, QA/RA, Clinical, Marketing, and Supply Chain teams to ensure regulatory requirements are considered throughout the product lifecycle and provide regulatory input for new product development, clinical studies, and marketing initiatives. Mentor and develop local regulatory staff or liaison teams and provide regulatory training to internal stakeholders. Application

What you should do now Apply to this job ad or send your CV across to me at for a confidential discussion. (Brunel International South East Asia Pte Ltd, Registration Number: R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R .) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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Key Result Areas (Regulatory) Adherence to AZ and industry codes of conduct, ethics, PhAMA code & Good Regulatory Practices. Maintenance of product licenses to a high standard throughout current year, with zero negative impact to business objectives & financial targets. Develop & implement regulatory strategy for responsible therapeutic area to achieve rapid & high-quality approvals & facilitate rapid launch. Provide guidance and functional support to regulatory team member. Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders. Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs. Proactive cross-functional teamwork contributing to optimum business strategies. Manage legal (including contracts) & Patent-related matters. Manage regulatory vendors and suppliers according to AZ requirements where applicable. Act as Company Pharmacist and Poison A License holder for the company. As Provisional Registered Pharmacist (PRP) Preceptor for the company (if require). Typical Accountabilities Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Regulatory Affairs. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance Education, Qualifications, Skills and Experience Essential Pharmacy or Scientific Degree or equivalent professional qualification in related field Minimal 5 years of experience in regulatory affairs area. Post-graduate qualification Key Relationships to reach solutions Internal Country Leadership Team Country Cross Functional Team (Quality Assurance, Commercial, Medical, Supply Chain, HR, Finance, Market Access/Tender, Corporate Communications) Manufacturing Site, GRAPSQA, Global Supply Chain Quality Functional Leadership Teams External Regulatory bodies Pharmaceutical companies Distributors Local Trade Associations HCPs & KEEs Date Posted 27-Ogo-2025

Closing Date 26-Sep-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#J-18808-Ljbffr

Biomed Global Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Regulatory Affairs Manager

Biomed Global Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Direct message the job poster from Biomed Global Talent Management Specialist |Just your friendly neighborhood Recruiter | Career Match-Maker|

I don't usually stalk Profiles, but when I do I…

Position:

Regulatory Affair Manager Industry:

Healthcare/ Medical Device Responsibilities Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory. Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA). Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements. Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments. Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows. Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities. Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies. Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements. Ensure compliance with advertisement and labeling regulations in each marketing territory. Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG). Plan and lead the implementation of internal RA audits on an annual basis. Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings. Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia. Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes. Support regulatory matters related to custom import requirements and documentation. Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health. Qualifications Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity. Required Skills Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint. Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training. Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers, effectively. In-depth knowledge and

hands-on experience in medical device registration and regulatory compliance , particularly in Malaysia, Singapore, and Indonesia. Solid

understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements. Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices. Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements. Meticulous and detail-oriented, capable of working independently with minimal supervision. Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights. Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution. Pharmacist background with a valid license will be an added advantage. Seniority level

Seniority level Not Applicable Employment type

Employment type Full-time Job function

Job function Management, Legal, and Strategy/Planning Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Biomed Global by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles.

Taman Tun Dr Ismail, Federal Territory of Kuala Lumpur, Malaysia 1 month ago Regulatory Affairs Senior Executive / Assistant Manager

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Regulatory Affairs Senior Executive / Assistant Manager

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 day ago Petaling Jaya, Selangor, Malaysia 3 days ago WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Senior Regulatory Affairs Specialist, APAC

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 6 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 8 months ago Petaling Jaya, Selangor, Malaysia 6 days ago Senior Manager / Manager ( Regulatory Assurance and Advisory Services – Prudential Regulation)

Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago Regulatory Compliance Manager, Markets and Securities Services - Malaysia

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 months ago Assurance - Manager/Senior Manager (Regulatory Assurance and Advisory Services)

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 5 days ago Senior Project Manager - Regulatory and Compliance

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 6 days ago PBTB| Assistant Manager, Projects and Regulatory

Assistant Manager, Financial and Regulatory Reporting M/F

SR&T Project Manager, Regulatory & Financial Risk

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Regulatory Affairs Associate ( 1 year contract)

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 5 days ago Cluster Medical & Regulatory Affairs Lead

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Manager_Markets Onboarding Regulatory Implementation

Bukit Jalil, Federal Territory of Kuala Lumpur, Malaysia 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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The Position **

This role is responsible for leading timely and successful product registrations in alignment with both corporate objectives and local regulatory requirements. It plays a critical part in ensuring full compliance with applicable laws, guidelines, and industry standards governing the importation, licensing, and control of therapeutic products.

You are require to collaborate with internal stakeholders and health authorities to navigate regulatory pathways efficiently and effectively. In addition to managing submissions and approvals, the role contributes strategic input to regulatory planning, supports cross-functional initiatives, and helps shape local regulatory strategies that enable market access and long-term business sustainability.

Duties and Responsibilities: **

1. Regulatory Planning and Submission Strategy

• Manage all regulatory tasks and projects, including obtaining and maintaining product and operational licenses for the assigned portfolio on behalf of BI, as required by local regulations.

• Prepare and submit regulatory applications for the assigned portfolio, ensuring timely approvals.

• Develop local registration plans in alignment with local business objectives and global regulatory strategy.

• Monitor the progress of submissions and coordinate timely responses to all questions from health authorities for the assigned portfolio.

• Ensure compliance with corporate policies, regulations, and procedures, particularly the implementation of the current Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures.

• Manage regulatory submissions to support clinical trial activities in the OPU, if applicable.

1. Regulatory Intelligence and Interaction

• Keep the local Regulatory Affairs (RA) team and ROPU informed of new regulations or updates.

• Ensure timely regulatory impact assessments.

• Maintain close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions.

• Communicate with health authorities and local industry groups on regulatory issues.

1. Cross-Functional Collaboration and Support

• Provide regulatory consultation and collaborate with local business stakeholders

• Ensure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the business

• Participate in the promotional material approval process to ensure regulatory compliance

• Provide feedback to global teams and participate in global initiatives when required

1. Quality and Compliance

• Ensure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIs

• Maintain regulatory databases to reflect current registration status and regulatory requirements

• Ensure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulations

• Contribute to audits, CAPA processes as appropriate, and support local inspection readiness

• Archive local regulatory submission documents in accordance with internal standards

1. Deputy Role and Training Support to Local RA Team

• Fulfill the responsibilities of the Head of Regulatory Affairs in their absence

• Act as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriate

Requirements: **

• Bachelor’s degree; Degree in Pharmacy preferred

• Over 7 years of experience in the pharmaceutical, medical device, or healthcare industry

• Background in regulatory affairs or a related discipline is an advantage

• Solid understanding of drug development and national regulatory procedures

• Technical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical)

• Proven ability to interact with health authorities and navigate local regulatory requirements

• Strong communication skills for both internal and external stakeholders

• Proficient in English (written and verbal)

• Comfortable working with databases; strong computer literacy

• Effective in cross-functional, matrix environments

• Proactive, assertive, and collaborative team player

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

#J-18808-Ljbffr

**The Position** ** **
This role is responsible for leading timely and successful product registrations in alignment with both corporate objectives and local regulatory requirements. It plays a critical part in ensuring full compliance with applicable laws, guidelines, and industry standards governing the importation, licensing, and control of therapeutic products.
You are require to collaborate with internal stakeholders and health authorities to navigate regulatory pathways efficiently and effectively. In addition to managing submissions and approvals, the role contributes strategic input to regulatory planning, supports cross-functional initiatives, and helps shape local regulatory strategies that enable market access and long-term business sustainability.
**Duties and Responsibilities:** ** **
1. Regulatory Planning and Submission Strategy
+ Manage all regulatory tasks and projects, including obtaining and maintaining product and operational licenses for the assigned portfolio on behalf of BI, as required by local regulations.
+ Prepare and submit regulatory applications for the assigned portfolio, ensuring timely approvals.
+ Develop local registration plans in alignment with local business objectives and global regulatory strategy.
+ Monitor the progress of submissions and coordinate timely responses to all questions from health authorities for the assigned portfolio.
+ Ensure compliance with corporate policies, regulations, and procedures, particularly the implementation of the current Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures.
+ Manage regulatory submissions to support clinical trial activities in the OPU, if applicable.
2. Regulatory Intelligence and Interaction
+ Keep the local Regulatory Affairs (RA) team and ROPU informed of new regulations or updates.
+ Ensure timely regulatory impact assessments.
+ Maintain close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions.
+ Communicate with health authorities and local industry groups on regulatory issues.
3. Cross-Functional Collaboration and Support
+ Provide regulatory consultation and collaborate with local business stakeholders
+ Ensure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the business
+ Participate in the promotional material approval process to ensure regulatory compliance
+ Provide feedback to global teams and participate in global initiatives when required
4. Quality and Compliance
+ Ensure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIs
+ Maintain regulatory databases to reflect current registration status and regulatory requirements
+ Ensure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulations
+ Contribute to audits, CAPA processes as appropriate, and support local inspection readiness
+ Archive local regulatory submission documents in accordance with internal standards
5. Deputy Role and Training Support to Local RA Team
+ Fulfill the responsibilities of the Head of Regulatory Affairs in their absence
+ Act as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriate
**Requirements:** ** **
+ Bachelor's degree; Degree in Pharmacy preferred
+ Over 7 years of experience in the pharmaceutical, medical device, or healthcare industry
+ Background in regulatory affairs or a related discipline is an advantage
+ Solid understanding of drug development and national regulatory procedures
+ Technical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical)
+ Proven ability to interact with health authorities and navigate local regulatory requirements
+ Strong communication skills for both internal and external stakeholders
+ Proficient in English (written and verbal)
+ Comfortable working with databases; strong computer literacy
+ Effective in cross-functional, matrix environments
+ Proactive, assertive, and collaborative team player
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

The Position

** This role is responsible for leading timely and successful product registrations in alignment with both corporate objectives and local regulatory requirements. It plays a critical part in ensuring full compliance with applicable laws, guidelines, and industry standards governing the importation, licensing, and control of therapeutic products. You are require to collaborate with internal stakeholders and health authorities to navigate regulatory pathways efficiently and effectively. In addition to managing submissions and approvals, the role contributes strategic input to regulatory planning, supports cross-functional initiatives, and helps shape local regulatory strategies that enable market access and long-term business sustainability. Duties and Responsibilities:

** Regulatory Planning and Submission Strategy Manage all regulatory tasks and projects, including obtaining and maintaining product and operational licenses for the assigned portfolio on behalf of BI, as required by local regulations.

Prepare and submit regulatory applications for the assigned portfolio, ensuring timely approvals.

Develop local registration plans in alignment with local business objectives and global regulatory strategy.

Monitor the progress of submissions and coordinate timely responses to all questions from health authorities for the assigned portfolio.

Ensure compliance with corporate policies, regulations, and procedures, particularly the implementation of the current Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures.

Manage regulatory submissions to support clinical trial activities in the OPU, if applicable.

Regulatory Intelligence and Interaction Keep the local Regulatory Affairs (RA) team and ROPU informed of new regulations or updates.

Ensure timely regulatory impact assessments.

Maintain close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions.

Communicate with health authorities and local industry groups on regulatory issues.

Cross-Functional Collaboration and Support Provide regulatory consultation and collaborate with local business stakeholders

Ensure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the business

Participate in the promotional material approval process to ensure regulatory compliance

Provide feedback to global teams and participate in global initiatives when required

Quality and Compliance Ensure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIs

Maintain regulatory databases to reflect current registration status and regulatory requirements

Ensure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulations

Contribute to audits, CAPA processes as appropriate, and support local inspection readiness

Archive local regulatory submission documents in accordance with internal standards

Deputy Role and Training Support to Local RA Team Fulfill the responsibilities of the Head of Regulatory Affairs in their absence

Act as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriate

Requirements:

** Bachelor’s degree; Degree in Pharmacy preferred

Over 7 years of experience in the pharmaceutical, medical device, or healthcare industry

Background in regulatory affairs or a related discipline is an advantage

Solid understanding of drug development and national regulatory procedures

Technical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical)

Proven ability to interact with health authorities and navigate local regulatory requirements

Strong communication skills for both internal and external stakeholders

Proficient in English (written and verbal)

Comfortable working with databases; strong computer literacy

Effective in cross-functional, matrix environments

Proactive, assertive, and collaborative team player

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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Overview

Manager, Regulatory Affairs — TNG Digital WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Job Brief

As the Manager of Regulatory Affairs, you will assist the Senior Manager in overseeing the company’s compliance efforts, working closely with stakeholders to develop, implement, and maintain compliance programs aligned with legal, regulatory, and industry standards, both locally and globally. You will work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution, while focusing on managing day-to-day operations of the regulatory affairs functions within the company and ensuring compliance with existing regulations and standards.

Responsibilities

• Assist in the development and implementation of regulatory compliance strategies and policies to align with company objectives and regulatory requirements, in Malaysia and globally.
• Monitor, analyse, and interpret regulatory updates from relevant authorities and advise business units on compliance with regulatory frameworks.
• Review and provide feedback on regulatory consultation papers, exposure drafts, and other legislative documents issued by Malaysian authorities.
• Manage regulatory related applications, submissions and reporting, ensuring compliance with approval requirements, deadlines, and policies.
• Lead the development and implementation of automated compliance processes, including reporting, approvals, and monitoring to improve operational efficiency.
• Monitor and track regulatory filings and approvals to ensure timely, accurate submissions and adherence to relevant requirements.
• Maintain an organized and up-to-date library of compliance documentation, including approvals, submissions, and correspondence.
• Stay informed on changes in laws, regulations, and industry standards, and update compliance programs as necessary and ensure the company’s licensing strategy aligns with these changes.
• Identify areas of improvement and recommend corrective actions to ensure compliance.
• Collaborate with cross-functional teams to provide regulatory guidance in product development, marketing, and operations.
• Serve as the secondary point of contact for regulatory authorities and external auditors, ensuring timely, accurate responses.
• Assist in the development and delivery of training on compliance policies and regulatory requirements.
• Build and maintain relationships with key stakeholders, including regulatory authorities, industry associations, and legal counsel.
• Prepare reports and or presentations for senior management on regulatory compliance activities, issues, and emerging trends.
• Provide concise and actionable insights and advice to stakeholders based on compliance requirements, records and regulatory updates.

Qualifications

• Bachelor's degree in business, law, finance, or a related field. An advanced degree is preferred.
• Ideally, 6 or more years of experience in regulatory affairs or a related field within the payments or financial services industry.
• Strong understanding of regulatory frameworks with the ability to interpret and apply complex legal and regulatory requirements to business operations.
• Proficient in leveraging data analysis software and AI tools to enhance operational efficiency and ensure accurate compliance management.
• Skilled in analysing complex proposals and developing actionable recommendations, using data and inputs from multiple stakeholders to support conclusions.
• Manage a variety of viewpoints to build consensus and create positive outcomes for all stakeholders.
• Ability to distil complex messages, simplifying key points for diverse audiences.
• Detail-oriented with proficiency in managing regulatory submissions, reporting, and compliance documentation, ensuring accuracy and timeliness in meeting legal and policy requirements.
• Strong analytical skills to assess regulatory risks and implement effective compliance strategies.
• Excellent communication skills (written and verbal), including the ability to negotiate, influence regulatory changes, and manage stakeholder relationships.
• Exceptional organizational and project management skills with the ability to prioritize tasks and manage multiple deadlines in a fast-paced environment.
• Proven ability to collaborate with cross-functional teams, providing guidance on regulatory matters in product development, marketing, and operations.
• Uphold the firm's code of ethics and business conduct.
• Flexi working hours.
• Monthly eWallet allowance.
• Additional 1% employer EPF contribution from your 1st to 3rd year of service, with further increases based on your continued years of service.
• Unlimited office pantry fruits, snacks and drinks.
• Mobile and broadband subscription reimbursement.
• Flexibility to opt dependants coverage (spouse, child, parents or parents-in-law) for outpatient medical benefits.
• Additional leave including family leave and paid care leave to care for family members.
• Medical coverage including dental, optometrist, mental care, maternity, registered Traditional Chinese Medicine TCM and Chiropractic.
• Corporate membership discount and many more to explore.

Equal Opportunity Statement

Touch ‘n Go is an organization that strives to provide Equal Opportunity Employment, based on merit, qualifications, capabilities, and calibre. It is Touch ‘n Go’s policy to not discriminate based on age, race, religion, colour or other personal status, identity or characteristics. Fair Opportunity is Our Value and Practice. Please advise us of any accommodations you may need by e-mailing:

Note: Only shortlisted candidates will be contacted

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting

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