81 Regulatory Affairs jobs in Malaysia

Overview

Title: Executive, Regulatory Affairs

Location: Petaling Jaya, MY, MY

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number:

Overview text retained from original job description while removing boilerplate and non-essential postings.

• Assist in timely variation submission via NPRA Quest system for pharmaceutical products, as well as product registration maintenance and document retention.
• Keep abreast of updated regulations in Malaysia.
• Liaise with local Regulatory Authorities to expedite regulatory approvals, and serve as the official liaison with government regulatory agencies and the Ministry of Health.
• Ensure proper documentation of all regulatory applications and communications with clients and Regulatory Authorities.
• Ensure DKSH (M) operations are in compliance with all applicable government laws and regulations.
• Ensure services provided are as agreed in RA agreements with Clients.
• Review promotional material, where DKSH is license holder, to ensure contents are fully supported by Product Information and literature, and in accordance with the PhAMA Code of Conduct and authorities’ guidelines.

• Pharmacovigilance (PV)
• Acts as local Pharmacovigilance associate supporting Primary Pharmacovigilance responsible person (RPPV).
• Liaises with Client PV contact persons for timely reporting of Adverse Drug Events and submitting these reports within the stipulated timelines.
• Liaises with Client PV contact persons for medical device expedited reporting.
• Perform periodic literature and NPRA MADRAC/Journal search.
• Maintain Pharmacovigilance Log, Periodic Safety Updates Report Logs and Product Safety Core Data Sheet.
• Responsible for reconciliation of PV logs with clients.

• Responsible for supervising the discharge of psychotropic drugs.
• Ensure company’s operations are in compliance with all Ministry of Health’s laws and regulations. Maintenance of the various licenses required to operate DKSH’s warehouse and distribution services.

• Minimum Bachelor's Degree in Pharmacy.

• Demonstrate knowledge in quality assurance tools, concepts and methodologies.
• Demonstrate knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS).
• Demonstrate basic understanding of the Global Harmonized System (GHS).
• Demonstrate good working knowledge of local regulations.
• Demonstrate proficiencies in office productivity tools (e.g., Excel, Word, PowerPoint).
• Demonstrate ability to work across cultures and respect cultural sensitivities in cross-country interactions.
• Demonstrate fluency in the local language and ideally in English, both written and spoken.

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Regulatory Services
• Industries: Transportation, Logistics, Supply Chain and Storage

Responsibilities

• Involve in Innovation projects - Advise project team on regulatory aspects and changes that would affect product manufactured.
• Prepare product technical documentation.
• Involve in product registration - Prepare product registration documents for the requested countries, work with regulatory body/ agency on required document for registration submission.
• To apply Free Sale Certificate & Manufacturing Certificate and arrange for legalization of certificates.
• Work with HQ on regulatory documents and release order.
• Support marketing on label changes and marketing material review.
• Other regulatory task as assigned.

• Degree in Science or Engineering.
• Preferable with minimum 3 year's working experience in Regulatory Affairs.
• Knowledge of ISO 13485.
• Knowledge of regulatory and registration document submission in ROW.
• Personal - Committed with positive attitude, flexible, good accountability and good team spirit.

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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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

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.

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

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

Direct message the job poster from Biomed Global

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 Not Applicable

• Employment type Full-time

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

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

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

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

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

Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago

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

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

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

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

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

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

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

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Job Description & Requirements

Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.

Responsibilities

· Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines

· Support regulatory assessment of submission requirements based on relevant regulations

· Assist with administrative work necessary to support regulatory activities

· Review and provide input for regulatory documents

· Support any other duties assigned

Qualifications

· Degree in Biological, Chemistry, or a related field

· No experience required. Must have an interest in Regulatory Affairs

· Keen learner with a strong attention to detail and organizational skills

· Proficiency in English (written and spoken) is required

Getz Healthcare, Taman Tun Dr Ismail, Federal Territory of Kuala Lumpur, Malaysia

The Regulatory Affairs Officer is responsible for supporting the product registration process primarily within Hong Kong and Singapore, ensuring compliance with regulatory requirements and facilitating timely approvals. This role involves coordinating with various external parties such as regulatory authorities, third party agents, business partners, and conformity assessment bodies (CAB); preparing and submitting documentation, and collaborating with internal teams to ensure adherence to local and international regulations.

By maintaining up-to-date knowledge of regulatory changes, the Regulatory Affairs Officer plays a key role in ensuring product approval with the health authorities.

• Ensuring compliance with local and international regulatory requirements for products and services.
• Communicating with business partners to gather documents required for product registration within the required time frame.
• Reviewing and analyzing business partner's documents, using a number of different methods including artificial intelligence (AI), for product registration in compliance with applicable regulations.
• Preparing, submitting, and managing regulatory filings, including applications, renewals, and changes.
• Collaborating with cross-functional teams and external agencies to ensure products meet legal, industry and quality management standards.
• Monitoring and interpreting changes in regulations to advise the company on necessary adjustments.
• Communicating with regulatory authorities and third-party agents to obtain approvals, resolve issues, and maintain compliance.
• Maintaining accurate documentation and records to support audits and inspections.
• Providing guidance and training to teams on regulatory requirements and best practices.
• Addressing regulatory inquiries and supporting risk management initiatives.

The Regulatory Affairs Officer will work in a hybrid environment, splitting time between remote work and in-office duties, as determined by your manager. The individual will be based in Malaysia and will collaborate with local and international teams.

• Education: Bachelor’s degree in medical, science or business-related discipline.
• Experience: Minimum of 2 years of combined experience in Regulatory Affairs, preferably with exposure to the healthcare or medical device industry.

• Strong proficiency in both written and spoken English, with excellent communication skills for liaising with internal and external stakeholders.
• Highly detail-oriented with an analytical mindset, ensuring accuracy in regulatory documentation and compliance assessments.
• Well-organized and capable of managing multiple regulatory processes efficiently.
• Proactive in problem-solving, with the ability to assess risks and determine appropriate solutions.
• Adaptability to evolving regulatory requirements and the ability to work in a fast-paced environment.
• Familiarity with relevant regulatory frameworks and digital tools for documentation management (e.g., AI, SharePoint).
• Handling electronic submissions and regulatory databases.

• Seniority level: Entry level
• Employment type: Other
• Job function: Legal
• Industries: Medical Equipment Manufacturing