JOB DETAILS

JOB DETAILJob Details

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.

1. RA
• 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 to the 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 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 and etc.

• To ensure good coordination with other affiliates, regional and global functions.

• To contribute RA inputs (e.g., regulatory strategies, timelines, labelling 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 professional working relationship with health authority.

2. PV

• 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 the regular training to ensure that they are aware of their Drug Safety responsibilities.

• To review and finalise the relevant agreement, including Pharmacovigilance Agreements with third parties (e.g., distributor) to ensure appropriate safety reporting processes are in place.

• To ensure 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.

3. QA

• To maintain local quality management system, SOPs, documents and processes in accordance to 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 labelling including timely implementation of artwork change.

• To handle product complaint in a timely manner according to SOP.

• To provide batch release approval.

• To review and finalise quality assurance agreement with third parties.

4. Other
• You may be assigned with other duties from time to time as required by the business.

REQUIRED WORK EXPERIENCERequired

✓ Qualification: Registered pharmacist

✓ Fluency in English and Bahasa Malaysia (written and spoken)

✓ Prefer Minimum 2 years or more in regulatory affairs/pharmacovigilance role in pharmaceutical company

✓ Able to work independently and with others, positive attitude, willingness to embrace new skills.

✓ Experience in CNS （Central nervous system）drugs（Preferable）

✓　 Details oriented,　good at finding discrepancy, incompliance

✓ Willing to learn new things

✓ Dealing with internal and external stake holders, (Sales, account, admin, HQ, Venders, distributors, Health Ministry etc)

✓ Make sure do right things, not speed. Deep consideration.