Role & responsibilities
Review of post approval changes and evaluating its impact on the products.
Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports.
Management of product life cycle.
Managing Team
Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics
Preferred candidate profile
10+ Years of USFDA post approval submission experience
USFDA Experience
Exposure to ANDA /NDA post approval submissions
Please share updated CV on hr*9@he************k.com
Keyskills: USFDA Regulatory Affairs Regulatory Submissions