Regulatory Affairs Pharmacist

Recruitment Supervisor at Ambica International Corporation

Regulatory Affairs Pharmacist ensures that the company complies with applicable FDA and other regulatory related government entities regulations on licenses, technical documents and product registrations. Sr. Regulatory Pharmacist is responsible for preparation, evaluation and submission of Initial application for Drugs, Food, Medical Devices and Cosmetics, PCPR and CLIDP renewals, GMP applications, LTO Inclusions and Variations. This is a desk-based role, involving the close study of scientific and legal documents.

• Responsible in ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to FDA to merit an approval and secure a Certificate of Product Registration.
• Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Food Initials, Medical Device Initials and Cosmetic Notifications.
• Responsible for renewal and revalidation of Principal Certificate of Product Registration and Certificate of Listing of Identical Product and ensure that the documents are overflowing with quality to secure the approval from FDA.
• Communicates Equivalence Evidence Study with the supplier, evaluates and prepares for submission. Makes sure that Bioequivalence Study Report meets the Criteria of ASEAN Guidelines, and the Biowaiver Study/Comparative Dissolution Profile meets the WHO Guidelines.
• Responsible for variation/amendment applications of Certificate of Listing of Identical Product and Principal Certificate of Product Registration.

• Must be a licensed/registered Pharmacist
• Knows how to operate Microsoft Office (MS Word, Excel, Powerpoint, Outlook), and PDF (Nitro Pro, Adobe etc).
• Can check documents for grammar, spelling, and punctuation errors.
• Highly self-motivated, goal-oriented, and committed to pursuing a long-term career.
• Exceptionally well organized and strong work ethic.

• Mid-Senior level

• Full-time

• Legal

• Pharmaceutical Manufacturing