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 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, and 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.
- Responsible in having follow-ups for the applications that were not yet evaluated by FDA for timely release of approval from FDA.
- Able to submit compliance on or before the deadline as prescribed by FDA.
- Prepares documents for PCPR and CLIDP Extensions.
- Prepares documents for regulatory purposes/FDA concerns such as LTO application and LTO Renewal.
- Responds to client/XD queries when it comes to applications and other corresponding concerns.
- Evaluates legal documents as per FDA requirements, makes sure that all Legal Agreements are valid upon submission to FDA.
- Keeps up-to-date with changes in regulatory legislation and guidelines and disseminates the updates to Regulatory Team.
- Ensures that quality standards are met and submissions meet strict deadlines for the applications.
- Assistance and processing of XD, Marketing and BD requests.
- Responsible for GMP Clearance Applications and GMP Application Renewals. Ensures that GMP Evidence Dossiers for Non-PICs countries are well evaluated.
- Responsible in submission of LTO Inclusion.
- Ensures that the country specific fees for applications are paid on time.
- Performs Quality Assurance on all artwork and ensures that labeling materials complies with FDA requirements and AO 2016-0008.
- Attends to Medical Mission hosted by Ambica International Corporation.
- Other duties as may be assigned by the management.