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