DRA

Formulation Production Experience - Bottle Packing Section Oral solid manufacturing, Sterilization, Granulation, coating and documentation as per SOP.

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. 

Accountable for regulatory transition activities to achieve relevant project turning points, as well as core business development operational activities including but not limited to running the green light process, preparation of documentation and risk, issue management.

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.

Bachelors, Master degree or PhD in science, math, engineering or related discipline; The Principal, Regulatory Affairs, Intelligence, Materials is expected to perform with minimal supervision and is an experienced and detail-oriented professional with expertise in materials and with an understanding of the interplay of materials and medical devices, pharmaceuticals and combination products.