Regulatory affairs

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.

Follows and implements the organizations consulting models and methodologies under the guidance of the project lead and/or Technical SME

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.

A Graduate, Post graduate in Pharmacy. Collation, compilation and timely dispatch of required regulatory documentation to Apotex affiliates/customer and follow-up on timely submission of applications to the health authority.

Ph.D. in relevant discipline with first class or equivalent at the preceding degree i.e. Master Degree in Pharmacy, Forensic Pharmacy with specialization in Pharmacology or relevant discipline with very good academic record throughout.