Assistant Manager, Regulatory Affairs
Preferred Qualification: M. Pharm. Preferred Experience: 8-12 yrs (for AM/DM level) Job Description: • Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals. • Working on due diligence projects for US, EU & Canada markets as per the business agreement. • Managing pre-approval portfolio including original submission, deficiency response, final approval request &...