Regulatory affairs

Masters degree in Life Sciences or equivalence scientific degree with minimum of 5-7 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven leadership, technical specialist role experience in health authority interactions

Prepare and review the responses to Health Canada requeue and Deficiency Letters in timely manner to ensure prompt regulatory approvals of dossiers under supervision of Deputy Manager.

Masters in Life Sciences. Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling

M.Pharm / M.Sc; Candidates with exposure in the pharmaceutical industry with biologics, preferably in regulatory affairs for highly regulated markets.

Regulatory Affairs Manager in the Regulatory Business Development Post Deal Management group is a regulatory specialist with project management capabilities responsible for both regulatory life cycle maintenance submissions and managing successful application transitions for products that are either divested or acquired.

Dossier submission and review of Module 1, 2 and 3. ANDA submission. DCP, MRP, National Filing for various EU countries. 

A Post-graduate, Graduate degree in Chemistry, Pharmacy, Life Sciences. Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US, CAN, EU, AUS-NZ, ROW markets.

Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation

They have to make dossier, Review the documents. Should have the knowledge of making CTD, ACTD and courtly Specific dossier.