Regulatory Pharmacist

Job Description

Regulatory Pharmacist ensures that the company complies with applicable FDA and other regulatory-related government entities regulations on licenses, technical documents, and product registrations. They are also responsible for the preparation, evaluation, and submission of Initial applications. This is a desk-based role, involving the close study of scientific and legal documents.

Job Responsibility

• Responsible for ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to the FDA to merit 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 o...