121 Regulatory Affairs Manager jobs in Malaysia

Brunel Federal Territory of Kuala Lumpur, Malaysia

Direct message the job poster from Brunel

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.

• 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.

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.

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.

Key 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.

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

Producing superior energy supplement feed products and non-genetically modified palm oil, Pulau Indah, West Port is home to over 200 employees. We have a wide-ranging global distribution network set up to cater to both present and future clients. We are the proud recipients of the esteemed FROST & SULLIVAN COMPANY OF THE YEAR award. This award was bestowed upon us in recognition of our unwavering commitment to providing products and services that meet the highest quality standards, our robust brand experience, and our persistent efforts to fortify consumer loyalty while expanding our brand internationally.

A multinational business based in Malaysia founded in 2004, Ecolex Sdn Bhd is focused on exports and develops and produces food ingredients ) and animal nutritional lipids ). We are committed to innovation to provide our clients with additional value, and we have partnered with one of the biggest palm oil companies in the area.

About the Role

We are seeking an experienced Regulatory Affairs Manager to oversee compliance and regulatory function across both the food and feed industries. The successful candidate will ensure that all products manufactured and sold, meet local and international regulatory requirements while supporting the company's business growth and market expansion.

Key Responsibilities:

• Lead and manage all regulatory affairs activities to ensure compliance with food and feed regulations.
• Develop and implement the company's regulatory strategy in alignment with business goals.
• Monitor, interpret, and communicate regulatory requirements, policies, and changes at national and international levels.
• Ensure timely registration, licensing, and approvals of products with relevant authorities.
• Provide regulatory guidance to cross-functional teams (R&D, QA/QC, Production, Procurement, Sales & Marketing and Supply Chain).
• Review and advise product labeling, health/nutrition claims, and advertising to ensure compliance with applicable regulations.
• Oversee regulatory submissions, renewals, and maintenance of licenses, permits, and certifications related to company products.
• Develop, review, and enforce regulatory SOPs.
• Prepare, submit, and maintain regulatory documentation, dossiers, and technical files for food and feed products.
• Act as primary liaison with government authorities, and regulatory agencies.
• Support audits, inspections, and internal compliance initiatives.
• Train and guide internal teams on regulatory matters and industry standards.
• Drive continuous improvement in compliance processes and regulatory strategies.

Job Requirements:

• Bachelor's degree in Food Science, Biotechnology, Veterinary Science, Regulatory Affairs, or related discipline.
• Minimum 10 years of regulatory experience in food, feed, or related industries, with at least 5 years in a leadership role.
• Strong knowledge of local and international regulations (e.g., FDA, MOH, DVS, DOE, JAKIM & etc.).
• Experience with product registration, licensing, labeling compliance, and regulatory submissions.
• Excellent communication and negotiation skills with regulatory authorities, certification bodies and internal stakeholders.
• Strong leadership, people management, and team development skills.
• Crisis management with problem-solving capability and project management skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Attention to detail and high level of integrity.
• Strategic mindset with the ability to balance product compliance with business needs.

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.

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

Job Type: Permanent

Pay: RM6, RM9,000.00 per month

Benefits:

• Flexible schedule
• Free parking
• Health insurance
• Maternity leave
• Opportunities for promotion
• Parental leave
• Professional development
• Work from home

Application Question(s):

• How many years of experiences working in healthcare or Medical Device Industry ?
• How many years experiences working with ISO 13485 and GDPMD?
• Experience in medical devices registration?
• Has hand on experiences working with regulatory authorities ?

Education:

• Bachelor's (Preferred)

Work Location: In person

Overview

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 required 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.

• 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

• 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

Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Location: Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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.