35 Regulatory Affairs Manager jobs in Malaysia

Overview

As a Regulatory Affairs Manager, you will serve as an interface to Regulatory and Global Product Development (GPD) partners within designated Business Units. Your role involves providing project leadership and expertise in managing the logistics of executing regulatory Clinical Trial Applications and Central Ethics submissions to regional partners and selected Health Authorities.

You will be responsible for collaborating with various business lines to lead operational submission activities for designated Clinical Trial Applications. Acting as a regulatory operational Subject Matter Expert, you will drive submission teams to ensure the timely delivery of globally compliant, submission-ready documents.

Responsibilities

What you will be doing:

• Develop and implement global submission management strategies for assigned protocols. Collaborate with study teams to manage regulatory activities, standards, and deliverables related to CTA submission development, including authoring Annex I and related documentation.
• Lead and participate in meetings to advocate for realistic timelines, understand project strategies, assess impacts, and present the status of global submission activities.
• Support and lead efforts to ensure high-quality, compliant submissions that adhere to industry, agency, and format guidelines, regulatory strategies, policies, and timelines.
• Coordinate with Core teams, SSU, Study Management, and relevant suppliers for essential documents and local documentation for HA and EC submissions and translations.
• Prepare, review, and support submissions to HA/Regional CTA Hub to obtain necessary approvals for clinical trial conduct.
• Manage translation coordination for core documents required for submission.
• Oversee the compilation of core packages, contribute to CTA documentation, and author necessary documents.
• Act as a local country liaison when required.
• Escalate, communicate, and resolve issues impacting submission builds or logistics of global submission delivery to regional and local partners or Health Authorities.
• Consult with SMEs on dossier requirements interpretation.

Qualifications

You are:

• Holding a BS/B.Sc in Pharmacy, Life Sciences, or equivalent relevant professional experience.
• Having in-depth understanding and proven experience with Clinical Trial Application and Central Ethics processes globally.
• Possessing technical aptitude with the ability to quickly learn and adapt to new software, regulations, and quality standards.

What ICON can offer you: Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more about working at ICON: . ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and reasonable accommodations for applicants with disabilities. If you need assistance during the application process, please let us know through the provided form: . We encourage you to apply even if you are unsure about meeting all requirements, as you may be the perfect fit for this or other roles at ICON.

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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.

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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.
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.

Join to apply for the Manager Regulatory Affairs role at PeopleLAKE Group

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Join to apply for the Manager Regulatory Affairs role at PeopleLAKE Group

We're Hiring: Manager Regulatory Affairs!

We are seeking an experienced and detail-oriented Manager Regulatory Affairs to lead our regulatory compliance initiatives and ensure adherence to all applicable laws and regulations. The ideal candidate will have extensive knowledge of regulatory frameworks, excellent analytical skills, and the ability to navigate complex regulatory environments while supporting business objectives.

Location: Kuala Lumpur, Malaysia

Work Mode: Work From Office

Role: Manager Regulatory Affairs

What You'll Do

Develop and implement comprehensive regulatory compliance strategies

Monitor regulatory changes and assess impact on business operations

Prepare and submit regulatory filings and documentation

Liaise with regulatory authorities and government agencies

Conduct regulatory risk assessments and audits

Provide regulatory guidance to cross-functional teams

What We're Looking For

Bachelor's degree in Law, Life Sciences, or related field

5+ years of regulatory affairs experience

Strong knowledge of Malaysian regulatory landscape

Excellent written and verbal communication skills

Detail-oriented with strong analytical abilities

Experience with regulatory submissions and compliance management

Ready to make an impact? Apply now and let's grow together!

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Other
• Industries IT Services and IT Consulting

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Clinical Research Associate (CRA), Clinical Trials Unit

To assist the Clinical Trials Manager (CTM) in management of the clinical trial portfolios and operations in line with the CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”).

Responsibilities:

Clinical Trial Operations:

Ensure all activities/tasks delegated are completed and meeting the defined objectives within the specified timeframe and resources

Working under the supervision of the CTM to:

• Develop clinical trials documentation and toolkits for CRMY sponsored Trials and Investigator Initiated Trials
• Plan and manage clinical trials conceived internally or externally
• Support the CTM in conducting study feasibility for new clinical trials

Study Monitoring:

• Coordinate with the respective clinical trial teams to organize periodical study monitoring visit (on-site or remotely) in ensuring trials are conducted in compliance to study protocol, GCP, ICH guidelines, ethics and regulatory requirements
• Advise clinical trial teams on matters pertaining to GCP compliance and propose resolutions to findings/issues identified during study monitoring visit
• Deliver monitoring report after each study monitoring visit

Data Management:

• Assist CTM in designing the eCRF and perform test on the EDC prior migration to production mode
• Assist CTM in drafting the CRF Completion Guideline and Data Monitoring Guide for new trials

Sample Management:

• Coordinate sample management for IITs including ensuring the sufficient supply of study materials to be provided to Site and updating Site on changes on the protocol relating to sample collection/processing
• Coordinate the shipment of biospecimen from Sites to CRMY lab
• Ensure all biospecimen are stored or archived as specified in study protocol

Escalate critical issues pertaining to Study and Site Management to CTM

Compliance and Quality Management:

• Work together with CTM and research teams to develop and refine Standard Operational Procedure (SOP) for clinical trial operations
• Provide consultation to study teams on the compliance to SOPs
• File and maintain GCP certificates of CRMY employee who are involved in Clinical Trial activities and provide information to CRMY staff on the latest GCP workshops in Malaysia

Other responsibilities include:

• To represent the team and Cancer Research Malaysia when appropriate
• To undertake other administrative tasks as required

Requirement:

• Educated to degree level (Life Science or related fields), with minimal 1-year clinical research or clinical monitoring experience
• Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local IRB/EC requirements
• Experience with study management SOPs
• Experience with EDC system such as REDCap and basic knowledge on data management
• Ability to establish links between various elements necessary to the proper conduct of the clinical study
• Meticulous, detailed, well-organized and able to work independently to meet datelines
• Excellent communication and interpersonal skills

We are an independent and non-profit cancer research organisation based in Malaysia. Funded by donations and research grants, we conduct research in niche cancers often found in our Asian population.

Cancer — the big ‘C’ — continues to be a stigma, only spoken about in hushed whispers; how it’s bad karma, how much it costs, and that nothing could be done.

Confronting this stigma head on, CRM has been reversing this language of cancer, transforming the big ‘C’ to a little ‘c’, and we plan to develop tools backed by good research to ensure that we can truly fight cancer on all fronts.

We believe that we will reverse the grip of cancer in our lives. We want researchers to win the war against cancer by turning it around with new ways of prevention and cure. We want to empower the public through impactful outreach programmes, with the hopes that Malaysians will respond differently to cancer by coming forward for screenings and going through with treatments.

Our driving force is held together by these goals:

• Improving the survival rates of Asian cancer patients, focusing on neglected areas of research.
• Empowering Asians to have the proper screening and treatment.
• Improving survival rates by being more accessible, focusing on providing existing cures to patients rather than sit on inaction and potentially losing lives.
• Making affordable and timely treatments by repurposing drugs, acknowledging the reality that developing new cures are costly and risky.
• Putting Malaysia in the global spotlight for cancer research by collaborating with top scientists around the world,and working to nurture the next generation of Malaysian cancer researchers.

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Clinical Research Associate (CRA), Clinical Trials Unit

To assist the Clinical Trials Manager (CTM) in management of the clinical trial portfolios and operations in line with the CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”). Responsibilities: Clinical Trial Operations: Ensure all activities/tasks delegated are completed and meeting the defined objectives within the specified timeframe and resources Working under the supervision of the CTM to: Develop clinical trials documentation and toolkits for CRMY sponsored Trials and Investigator Initiated Trials Plan and manage clinical trials conceived internally or externally Support the CTM in conducting study feasibility for new clinical trials Study Monitoring: Coordinate with the respective clinical trial teams to organize periodical study monitoring visit (on-site or remotely) in ensuring trials are conducted in compliance to study protocol, GCP, ICH guidelines, ethics and regulatory requirements Advise clinical trial teams on matters pertaining to GCP compliance and propose resolutions to findings/issues identified during study monitoring visit Deliver monitoring report after each study monitoring visit Data Management: Assist CTM in designing the eCRF and perform test on the EDC prior migration to production mode Assist CTM in drafting the CRF Completion Guideline and Data Monitoring Guide for new trials Sample Management: Coordinate sample management for IITs including ensuring the sufficient supply of study materials to be provided to Site and updating Site on changes on the protocol relating to sample collection/processing Coordinate the shipment of biospecimen from Sites to CRMY lab Ensure all biospecimen are stored or archived as specified in study protocol Escalate critical issues pertaining to Study and Site Management to CTM Compliance and Quality Management: Work together with CTM and research teams to develop and refine Standard Operational Procedure (SOP) for clinical trial operations Provide consultation to study teams on the compliance to SOPs File and maintain GCP certificates of CRMY employee who are involved in Clinical Trial activities and provide information to CRMY staff on the latest GCP workshops in Malaysia Other responsibilities include: To represent the team and Cancer Research Malaysia when appropriate To undertake other administrative tasks as required Requirement: Educated to degree level (Life Science or related fields), with minimal 1-year clinical research or clinical monitoring experience Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local IRB/EC requirements Experience with study management SOPs Experience with EDC system such as REDCap and basic knowledge on data management Ability to establish links between various elements necessary to the proper conduct of the clinical study Meticulous, detailed, well-organized and able to work independently to meet datelines Excellent communication and interpersonal skills We are an independent and non-profit cancer research organisation based in Malaysia. Funded by donations and research grants, we conduct research in niche cancers often found in our Asian population. Cancer — the big ‘C’ — continues to be a stigma, only spoken about in hushed whispers; how it’s bad karma, how much it costs, and that nothing could be done. Confronting this stigma head on, CRM has been reversing this language of cancer, transforming the big ‘C’ to a little ‘c’, and we plan to develop tools backed by good research to ensure that we can truly fight cancer on all fronts. We believe that we will reverse the grip of cancer in our lives. We want researchers to win the war against cancer by turning it around with new ways of prevention and cure. We want to empower the public through impactful outreach programmes, with the hopes that Malaysians will respond differently to cancer by coming forward for screenings and going through with treatments. Our driving force is held together by these goals: Improving the survival rates of Asian cancer patients, focusing on neglected areas of research. Empowering Asians to have the proper screening and treatment. Improving survival rates by being more accessible, focusing on providing existing cures to patients rather than sit on inaction and potentially losing lives. Making affordable and timely treatments by repurposing drugs, acknowledging the reality that developing new cures are costly and risky. Putting Malaysia in the global spotlight for cancer research by collaborating with top scientists around the world,and working to nurture the next generation of Malaysian cancer researchers.

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To ensure regulatory compliance for cosmetics by managing E-notification processes with NPRA, reviewing product dossiers and artworks, and coordinating registration renewals and compliance checks. This role is essential for import clearance, maintaining the product registration database, and ensuring adherence to labelling guidelines.

Main Roles and Responsibilities:

• Coordinate large scale regulatory data management to assigned centralized cloud platforms
• Conduct Regulatory Data Compliance Audits to govern integrity of data
• Collect, organize and maintain data for regulatory submissions
• Stay updated with Country /Brand Regulatory Leads and coordinate data requests
• Lead change management processes regionally
• Manage data extraction processes with tools provided
• Prepare reports summarizing regulatory notification status

Added Advantage

• Able to use end to end Regulatory Data management softwares
• Proficiency in data management principles and best practices

• B.Sc Information Management

• Familiarity with data management software and databases

• Strong communication skills, excellent spoken and written English
• Any working experience in regulatory fields at the following industries welcomed, cosmetics, food and Pharmaceutical
• Minimum 3-6 years working experience. Candidates who have internship experience in regulatory data management roles in pharmaceutical industries may also apply.

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To ensure regulatory compliance for cosmetics by managing E-notification processes with NPRA, reviewing product dossiers and artworks, and coordinating registration renewals and compliance checks. This role is essential for import clearance, maintaining the product registration database, and ensuring adherence to labelling guidelines.

Main Roles and Responsibilities:

• Coordinate large scale regulatory data management to assigned centralized cloud platforms
• Conduct Regulatory Data Compliance Audits to govern integrity of data
• Collect, organize and maintain data for regulatory submissions
• Stay updated with Country /Brand Regulatory Leads and coordinate data requests
• Lead change management processes regionally
• Manage data extraction processes with tools provided
• Prepare reports summarizing regulatory notification status

Added Advantage

• Able to use end to end Regulatory Data management softwares
• Proficiency in data management principles and best practices

• B.Sc Information Management

• Familiarity with data management software and databases

• Strong communication skills, excellent spoken and written English
• Any working experience in regulatory fields at the following industries welcomed, cosmetics, food and Pharmaceutical
• Minimum 3-6 years working experience. Candidates who have internship experience in regulatory data management roles in pharmaceutical industries may also apply.

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Direct message the job poster from Gentle Supreme Sdn Bhd

Head of Human Resources at Gentle Supreme

Job Summary

The Regulatory Affairs Executive plays a key role in ensuring the company’s products and operations comply with regulatory requirements and industry standards. This role includes the preparation of registration dossiers, coordination with authorities, and active support in legal matters such as trademark registration. The position is critical in supporting market access, product compliance, and brand protection.

Key Responsibilities

• Prepare and submit product registration dossiers to relevant regulatory authorities (e.g., NPRA, MOH, MDA) for approval and renewals.
• Monitor and ensure compliance with local and international regulatory requirements.
• Liaise with regulatory agencies, certification bodies, and internal stakeholders to ensure timely approvals and responses to inquiries.
• Maintain updated regulatory documentation, approvals, licenses, and internal tracking systems.
• Support in trademark registration processes, including coordination with legal counsel or trademark agents, submission of applications, renewals, and tracking of status.
• Review and validate product labels, packaging, promotional materials, and technical documents to ensure regulatory compliance.
• Assist in regulatory aspects of new product development, product variation, and post-marketing surveillance.
• Support internal and external audits related to regulatory and compliance matters.
• Stay informed on relevant laws, regulatory changes, and industry updates.
• Prepare periodic reports and summaries for internal use or regulatory submission.

Requirements

• Bachelor’s Degree in Legal, Chemistry, Intellectual Property Law or related discipline.
• 3–4 years of experience in regulatory affairs or compliance roles.
• Familiar with Malaysian regulatory frameworks and agencies such as MOH, NPRA, MDA, and MyIPO (for trademarks).
• Good understanding of regulatory documentation, product registration, and compliance standards.
• Strong attention to detail, analytical, and organizational skills.

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Legal and Product Management
• Industries International Trade and Development and Wholesale Import and Export

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