Regulatory Affairs jobs in Malaysia

This role will support regulatory affairs (RA), pharmacovigilance (PV), and quality assurance (QA) functions, including submission of new drug application (NDA) of new products, maintenance of existing products, maintenance of local pharmacovigilance system, and maintenance of local quality management system.

• To ensure proper submission of NDA to the health authority (NPRA), including but not limited to, compilation of dossiers and preparation of product information (e.g., package insert and artwork of package materials).
• To ensure accurate reporting and compliance with regulatory requirements.
• To be responsible for all regulatory affairs matters after NDAs, including but not limited to, new indications, variations, and registration renewals.
• To maintain and archive complete records/files of all product dossiers including updates submitted and approved, in online system and shared folder.
• To manage Import License and associated Product List in a timely manner to ensure continuous supply of stock.
• To ensure all licenses are valid, including company licenses, product licenses, and authority certification for external partners such as GMP certificates.
• To ensure good coordination with other affiliates, regional, and global functions.
• To contribute RA inputs (e.g., regulatory strategies, timelines, labeling change, stock impact during transition period, etc.) for ad-hoc projects such as assessment of new in-license products.
• To keep abreast with the latest regulatory requirements and update the team if there is any potential impact on company operation.
• To establish and maintain a professional working relationship with health authority.

• To manage safety queries and other significant safety information locally, inclusive of crisis management.
• To maintain and implement necessary SOPs that meet the requirements of the regulations with respect to drug safety.
• To ensure proper and timely collection, reporting, and managing of safety information of the products of the Company in accordance with the regulatory requirements.
• To ensure sufficient management of safety information to enable head office to perform a comprehensive and accurate assessment.
• To conduct local literature search and ensure any other safety data deemed fit for inclusion in the PSUR/PBRER or signal management process.
• To provide non-safety staff with regular training to ensure that they are aware of their Drug Safety responsibilities.
• To review and finalize the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.
• To ensure the company is ready for pharmacovigilance audits and inspections.
• Continual risk assessment of local PV operations, including early notification of any risks.
• To review and approve promotional and educational materials.

• To maintain local quality management system, SOPs, documents, and processes in accordance with GxP and related regulations and in alignment with company requirements and objectives.
• To ensure all aspects of handling and distribution of pharmaceutical goods in the country comply with relevant regulatory and legislative requirements.
• To ensure compliance of product labeling including timely implementation of artwork change.
• To handle product complaints in a timely manner according to SOP.
• To provide batch release approval.
• To review and finalize quality assurance agreements with third parties.
• You may be assigned other duties from time to time as required by the business.

Requirements

• Qualification: Registered pharmacist.
• Fluency in English and Bahasa Malaysia (written and spoken).
• Prefer Minimum 2 years or more in regulatory affairs/pharmacovigilance role in a pharmaceutical company.
• Able to work independently and with others, positive attitude, willingness to embrace new skills.
• Detail-oriented, good at finding discrepancies, non-compliance.
• Willing to learn new things.
• Dealing with internal and external stakeholders (sales, account, admin, HQ, vendors, distributors, health ministry, etc.).
• Make sure to do the right things, not speed. Deep consideration.

Additional Information

Industry: Pharmaceuticals

Working Hours: Monday to Friday, 8:45 am - 5:00 pm

If you're interested in this position, click "APPLY NOW".

Thank you for your application. Those who are shortlisted will be contacted. Stay tuned!