Regulatory Affairs Associate/ Senior Associate

Position Purpose

The Regulatory Affairs Associate/Senior Associate is responsible for Rebranding project and other activities pertaining to product registration, regulatory submissions and approvals. He/she is also responsible for developing packaging artworks of registered products, ensuring compliance to the company SOP and ensuring that the company's legal compliance is in line with relevant regulations. The Regulatory Affairs Associate/Senior Associate also provides regulatory advice to Company colleagues.



Primary Responsibilities:

1. Rebranding project: Develop strategy, coordinate with internal (local & regional) & external stakeholders to execute rebranding project (Legal Entity Name Change, Logo artwork change, Trade dress change, Manufacturing site legal entity name change)



2. Regulatory Submission & Approval (renewal registration, variation registration, new registration as assigned by RAL):

- Prepare, submit, coordinate and follow up on product registration as assigned.

- Variation registration: CMC, labeling update, artwork change...

- Ensure timely approval according to product registration plan.

- Keep contact with concerned parties abroad or in local.

- Provide information/documents as per requirements of internal or external stakeholders including Health Authorities (Ministry of Health) to conform to Company's regulations and law.

- Handle any amendments to registered products under responsibility.



3. Ensure the compliance of reporting adverse event/quality issue as regulation.



4. Ensure the compliance of relevant regulation of Ministry of Health and other concerned authorities



5. Coordinate with supply chain department to support for product's availability on market.



6. Maintain awareness of changes to laws, regulations and requirements and keep other departments informed of these changes as soon as possible



7. Provide professional comments, recommendations and requested information on legal documents to local and oversea colleagues.



8. Product Advertising and Promotional Material

- Provide regulatory comments/advice to Marketing in developing promotional materials and product advertising activities according to the relevant SOP.

- Support Marketing to follow-up with MOH on advertising/promotional pieces for urgent issues.



9. Packaging Artwork Development

- Coordinate with AW/plant's colleagues in developing the artwork for packaging materials of products in responsible portfolio.



10. Coordinate with Head Quarter and other partners when required.



11. Other projects assigned by Head of Regulatory Affairs



Report to: Direct report to Head of RA