1. Handling filing of ANDA for USFDA. 2. Review of formulation related documents like PDR (as per QBD concept), BMR, BPR, stability protocols & Stability Data. 3. Handling post approval changes,PAS and supplement filinge..
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Engineering Design, R&D
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Director
Desired Candidate Profile
UG: B.Pharma - Pharmacy
PG: M.Pharma - Pharmacy
- * Review of Specification, CQA of API, raw material, Packaging material and finished Products.
*Compilation of Documents as per eCTD requirement for CMC section for module 1 to Module 3 and annual updates.
* Co-ordination with documentation
Contact Company:Sai Placement