Careers

Job Requirements

• Bachelor Degree in Pharmacy, Applied Science, Science Nutrition or any related discipline.
• Excellence communication skills (spoken and written in English and Bahasa Malaysia) and Interpersonal skills.
• Basic computer skills such as Microsoft Office, etc.

Key Responsiblities

1. Coordinate clinical studies (Bioequivalence (BE) studies) of products manufactured/contract manufactured by Kotra Pharma. To adhere to project milestones in order to assure timely submission of new products.
2. Act as contact point with the Contract Research Organizations (CRO) for queries pertaining to registering and maintaining product licenses. Always respond and attend to queries forwarded by Senior RE/RE (from regulatory authorities) in a timely manner.
3. Responsible for application of license and variations (if any) of Clinical Trial Exemption (CTX) and Clinical Trial Import License (CTIL).
4. Maintains all study documents in an organized manner and in safe custody.
5. Issuance of Regulatory Alert to all the related department.
6. Responsible for preparation and update of Periodic Safety Update Report (PSUR), Risk Management Plan (RMP), Pharmacovigilance Site Master File (PSMF) and other pharmacovigilance related documents.
7. To assist in implementing regulatory requirements and impart information about the current approach of regulatory authorities to relevant departments in Kotra Pharma.
8. Assist head of department in conducting training pertaining to BE, PSUR and RMP for internal staff or external.
9. Assist head of department in sourcing of information pertaining to product or regulatory requirements.
10. To comply & work towards meeting the Company's quality policy, health, safety and environment objectives and policies; and quality system requirements.
11. Complies to Good Document Practice and Good Clinical Practice.
12. To participate in internal quality audit and other relevant audit.