176 Regulatory Affairs jobs in Malaysia

Educational Background

• Minimum: Bachelor's degree in relevant fields
• Preferred (senior roles): MSc in Regulatory Affairs / Pharmaceutical Sciences / Public Health / Pharm.D / Ph.D.
• Relevant disciplines include Life Sciences (Biology, Biochemistry, Microbiology), Pharmacy, Chemistry, Biomedical Science, medicine and nursing, Engineering (especially medical devices), or Law (for regulatory legal roles).

Skills & Knowledge

1. Knowledge of regulatory guidelines: FDA, EMA, NPRA (Malaysia), ICH, ISO, ASEAN

2. Understanding of:

3. Clinical trial processes

4. Product lifecycle
5. GMP / GDP / GCP
6. Strong documentation and submission skills (dossiers, variation applications, registration files)
7. Communication & negotiation with regulators
8. Attention to detail and project management

Experience

• Entry-level: Fresh graduates with relevant degrees and internships/coursework in regulatory fields
• Mid/Senior-level: 2–10+ years in Regulatory Affairs, QA, or Clinical

Malaysia-Specific Knowledge

• Familiarity with NPRA, DCA, and MDA guidelines is highly preferred.

For your information, our company is currently engaging Pharmacosip Consultancy to support all external matters related to pharmaceuticals, food, and cosmetic products (e.g., registration, licensing, labelling compliance, advertising review, GDP documentation).

However, during Good Distribution Practice (GDP) audits conducted by the NPRA, it is generally required that an internal staff member (Responsible Person, RP) be present to:

• Answer queries from NPRA inspectors
• Provide access to SOPs, distribution records, temperature logs, recall procedures, etc.
• Accompany inspectors during physical inspections of storage areas, vehicles, equipment
• Demonstrate GDP implementation and explain compliance procedures
• Rectify or explain non-conformities where possible

Hence, we are particularly looking for candidates who can take on this Responsible Person (RP) role and fulfil these obligations during audits.

Technical

• Provide prompt and accurate technical information to internal and external stakeholders, ensuring clarity and consistency.
• Support formulation reviews during the product development stage by collaborating with RA Director and R&D teams to ensure alignment with regulatory and technical requirements.
• Work with RA, R&D, Marketing, and international teams to evaluate and leverage product claims while ensuring compliance with local guidelines.
• Conduct technical review of reports and data that will be included in regulatory submissions, ensuring accuracy and completeness.
• Identify and interpret relevant regulatory guidance, directives, and orders from local authorities, providing practical insights and recommendations.
• Maintain up-to-date knowledge of current and emerging regulations, industry standards, and best practices.
• Recommend improvements or changes to company procedures in line with updated regulatory requirements.
• Oversee and coordinate the collection of laboratory samples for testing or evaluation as requested by relevant laboratory agencies.

Regulatory

• Ensure end-to-end compliance with regulations related to product registration, post-market surveillance, audits, license renewals, and all documentation processes.
• Prepare, initiate, and coordinate product submissions to regulatory agencies, ensuring complete documentation and timely approvals.
• Engage in direct communication with regulatory agencies on pre-submission strategies, pathways, compliance test requirements, and follow-up actions during reviews.
• Manage product variation submissions (e.g., production transfers, second source manufacturers, contract manufacturers) with supporting documents provided by international teams.
• Liaise closely with local authorities to obtain and maintain commercial licenses within the required timelines.
• Collaborate with RA Director and QA teams to address and respond to regulatory questions, clarifications, or audits.
• Ensure strict adherence to regulatory SOPs and corporate processes in all submissions and compliance activities.
• Maintain proper records of permits, licenses, and product registration files for audit and reference purposes.
• Prepare and submit advertising and promotional materials (e.g., KKLIU, MDTCA) for pre-approval before public release.
• Provide regulatory insights and updates to Marketing teams to guide campaigns and product positioning.

Industry Relations

• Represent the company in key trade associations (e.g., DSAM, MADSA, CTFAM) to strengthen industry presence and stay updated on regulatory developments.
• Foster strong working relationships with the Ministry of Health and other relevant authorities, ensuring smooth communication and quicker resolution of submissions.
• Monitor and report on the evolving regulatory environment, highlighting changes that may impact the business.
• Prepare timely responses to government or industry association requests such as product data submissions, surveys, or questionnaires.

Quality Assurance

• Uphold consumer trust and product reputation by addressing, resolving, and preventing recurrence of product quality-related complaints.
• Analyse customer complaints and product feedback to identify root causes and recommend corrective or preventive measures.
• Coordinate recall or market withdrawal activities in collaboration with authorities, if required.
• Manage and supervise product sampling for routine quality checks and regulatory compliance.
• Ensure product specifications and related documents (e.g., Certificates of Analysis, Finished Product specs) remain consistent with registered details.
• Maintain and continuously improve QA Standard Operating Procedures to ensure best practices in quality management.

Requirements

Qualifications

• Bachelor's Degree in Pharmacy or Science (Life Science or Chemistry preferred).

Experience

• 4–5 years of experience in technical/regulatory roles, particularly in health supplements, traditional medicine, or cosmetics.
• Strong knowledge of local regulations and proven experience with registration matters.

Skills & Attributes

• Analytical skills with attention to detail, problem-solving, and sound decision-making.
• Strong interpersonal, communication, and presentation skills.
• Proactive self-starter with ability to manage workload independently.
• Fluent in English and Bahasa (written and spoken).

Please kindly send in your updated CV to

We regret that only shortlisted candidates will be notified.

A seasoned Regulatory Affairs & Product Development Strategist to provide consulting services. This role requires deep expertise in Regulatory Affairs, CMC, and Clinical & Product Development, with a strong understanding of the Chinese regulatory landscape and global frameworks. The role will advise clients across the drug development lifecycle, shape regulatory strategy, support submissions, optimize CMC processes, and provide guidance on clinical and product development initiatives.

This role demands exceptional leadership, strategic acumen, and a results-driven mindset, a professional who not only navigates complexity but also defines the roadmap for innovation and regulatory excellence in the life sciences sector.

Key Impact Areas:

Regulatory Affairs Strategist & LCM

• Define and execute regulatory strategies for IND/CTA, NDA, MAA, BLA, and ANDA, ensuring seamless approvals.
• Guide clients on priority review pathways, fast-track approvals, and strategies to optimize regulatory submissions.
• Spearhead interactions with regulatory authorities; guiding, preparing and attending pre-IND and pre-NDA meetings.
• Oversee submission best practices and help mitigate regulatory challenges.
• Support Labeling and packaging materials development and update.
• Experience in Pharmacovigilance execution.
• Lead lifecycle management strategies, ensuring compliance and sustained market viability.

CMC Excellence & Strategy

• Provide expert guidance on manufacturing processes, technology transfer, and process validation.
• Lead clients through CMC-related regulatory filings, ensuring high-quality submissions.
• Advise on formulation development, analytical methods, and compliance with NMPA and global regulatory standards.

Clinical Development Strategy and Execution

• Design integrated clinical development strategies aligned with regulatory and commercial goals.
• Guide clients through clinical trial design, execution, and post-market surveillance.
• Oversee product development lifecycle management, including market expansion and commercialization strategies.
• Provide strategic input on formulation development and scalability for manufacturing.
• Lead interactions with CROs, vendors, and regulatory bodies, ensuring flawless execution and compliance.
• Provide deep insights into market expansion opportunities, driving competitive advantage.

Qualifications & Leadership Profile:

• 15+ years of executive-level experience in Regulatory Affairs/CMC, and Clinical Development.
• Proven track record of developing regulatory and clinical strategies and driving successful submissions and approvals in China and global markets.
• Experience in leading teams and project management within life sciences.
• Previous experience at a director level or above in an MNC or consultancy (CRO/CDMO experience) preferred.
• Registered Pharmacist, preferred.
• Expertise in small molecules, biologics, combination products, and ATMPs.
• Fluency in English and Chinese (Mandarin) for strategic client and regulator interactions.
• An entrepreneurial mindset, capable of handling both strategic leadership and administrative tasks.
• PhD or prior health authority experience (preferred but not mandatory).

SUN PHARMA WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

To ensure compliance with national and international regulatory requirements by preparing, reviewing, and submitting product registration dossiers and variations, while supporting cross-functional teams in maintaining product quality, safety, and efficacy.

Key Responsibilities :

Regulatory Submission & Compliance

• Prepare, compile, and submit product registration dossiers to regulatory authorities (e.g., NPRA and HSA) within stipulated timelines.
• Handle applications for new registrations, renewals, variations, and post-approval commitments.
• Maintain regulatory databases and tracking systems to ensure up-to-date product status.

Documentation & Review

• Review and ensure accuracy of product labeling, artwork, packaging, and promotional materials in compliance with regulatory guidelines.
• Maintain and update regulatory files, records, and product dossiers.
• Review technical documents (e.g., CMC, stability data, clinical reports) to ensure regulatory compliance.
• Monitor and interpret changes in local and international regulations, guidelines, and standards.
• Provide regulatory guidance to internal teams (R&D, QA/QC, Production, Marketing).
• Act as a point of contact between the company and regulatory authorities.
• Coordinate with external stakeholders (regulatory consultants, partners, contract manufacturers).
• Support audits and inspections by health authorities.

Cross-Functional Support

• Work closely with Quality Assurance (QA) and Quality Control (QC) to ensure compliance with GMP and GDP.
• Support product lifecycle management and regulatory strategy for new product development.
• Cross-functional communication to ensure smooth regulatory submissions and compliance.

Job Requirements :

• Bachelor’s degree in Pharmacy or a related field (e.g., BPharm, PharmD)/ Biomedical Sc./Other health Life sciences/Science).
• Familiar with NPRA, HSA, ASEAN, ICH guidelines.
• Proficiency in managing regulatory databases and tools.
• Knowledge of adverse event reporting systems and safety databases.
• Ability to review and manage regulatory and safety documents with precision.
• Strong ability to liaise with regulatory authorities, internal teams, and external stakeholders.

• Associate

• Full-time

• Business Development and Sales
• Pharmaceutical Manufacturing

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

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.

• 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.

• 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.

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

• Mid-Senior level

• Full-time

• Consulting

Overview

This position is responsible for leading Gan & Lee Pharmaceuticals’ regulatory affairs activities in the U.S. and European markets. This role oversees strategy development, submissions, and compliance with FDA, EMA, and other key authorities, ensuring timely approval of innovative medicines. The VP will manage the regulatory team, budgets, and operational processes, while fostering cross-regional collaboration to support the company’s global expansion, particularly in metabolic disease areas.

• Advanced degree (Master’s or above; PhD preferred) in Pharmacy, Medicine, Biology, Chemistry, or related fields
• Professional certifications in regulatory affairs (e.g., RAC) are preferred

• Minimum 15 years’ experience in regulatory affairs, including at least 10 years directly engaging with FDA/EMA
• Proven senior leadership experience in multinational pharma/biotech with successful IND/NDA/BLA or MAA approvals
• In-depth knowledge of regulatory pathways for metabolic diseases (e.g., diabetes, obesity) strongly preferred
• Familiarity with regulatory requirements across all phases of clinical development (Phase I–III and post-marketing)
• Demonstrated success in complex, matrixed organizations, working effectively with R&D, clinical, commercial, and quality teams

• Deep expertise in FDA and EMA regulations and approval pathways
• Strong strategic and forward-thinking mindset with proven decision-making in dynamic environments
• Excellent cross-cultural communication and negotiation skills
• Exceptional leadership and team-building skills with the ability to inspire international teams
• Proficiency in budget management, process optimization, and organizational efficiency
• Fluency in English (written and spoken); additional languages such as Mandarin are a plus

• Develop and execute regulatory strategies for the U.S. and EU markets, supporting the full product lifecycle from clinical trials to registration
• Lead interactions with FDA, EMA, and other authorities, ensuring submissions are scientifically robust, complete, and timely
• Represent the company in regulatory meetings, hearings, and negotiations to enhance visibility in the international regulatory arena
• Lead and develop the regional regulatory affairs team, including daily management, talent development, and performance evaluation
• Oversee regulatory affairs budgets, ensuring alignment of resources with corporate priorities
• Implement and optimize regulatory processes and knowledge databases to drive efficiency and cross-regional collaboration
• Monitor regulatory policy changes and assess their impact on company projects and commercialization plans
• Collaborate closely with R&D, clinical, commercial, pharmacovigilance, and quality teams to provide regulatory and market access insights

This position offers flexibility to be based in either Europe or the United States. The role may be structured as hybrid (on-site and remote) or fully remote, depending on candidate preference and business needs.

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

Closing Date

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.

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 .)

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The rapidly changing regulatory environment makes this job an interesting challenge. We have to be adaptable and think strategically every day.

Regulatory requirements are anything but static; they vary from one product to another, from country to country, and they evolve over time.

Staying abreast of it all is a full-time job in and of itself. Our people in regulatory affairs are tasked with keeping track of regulatory developments and boiling the information down into concise and comprehensible summaries for the relevant business units and departments. They must be self-reliant, but agile and able to work as part of a team.

Join a company with a global vision and a fast-growing network of experts and professionals deployed around the world.

Broaden your horizons, enhance your expertise, and advance your career working with many different business units and regions on a wide range of products and applications.

Use your technical expertise and scientific understanding of our products to advise and assist our decision makers in regulatory matters.

Advocate for our industry’s positions on questions of consumer health, ethical business practices, environmental concerns, and more. Liaise across our network to keep the relevant people up to date with the information they need to ensure regulatory compliance.

When you have locations in over 55 countries, there is no shortage of new opportunities!