Associate Regulatory Affairs Manager

To hold the Pharmacist Poison License Type A for the company to operate in Malaysia ; and other licenses where appropriate [applicable for registered pharmacists only]. To register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei. To renew and maintain Product Registration Licenses in Malaysia and Brunei. For Brunei,it is via a Third-Party Agent. Perform Life-Cycle Management of all registered products in Malaysia & Brunei such as PI/PIL Update, Artwork Changes, CMC Changes, Change of Sites, New Indications & Dosages Variations, and all other changes that affect the registered information within Regulatory Authorities in Malaysia & Brunei. To be the custodian for all matters pertaining to the registered products including archiving and retention of the product files. To create and approve artworks in Artwork Management System. To ensure the created and approved Artworks for Market Specific Pack (MSP), Shared Pack, Multi Market Pack, General Export Pack (GEP), and all other Supplied artworks are in compliance with relevant national, regional and global labelling requirements. To ensure compliance to QMS processes and Artwork Management SOP for Pharma and Vaccines. To ensure timely revision of SOPs for compliance to the current regulatory requirements.