- Collate and review CMC documents (e.g., Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports) from F&D, ADL, QA, production, and packaging departments. Review data for ANDA preparation, deficiency responses, annual reports, and supplements.
- Prepare and review ANDA sections.
- Compile controlled correspondences for excipients, Q1/Q2 queries, BE guidance, and general queries to the FDA.
- Assist in the development of regulatory strategies and their implementation to manage complex issues that may significantly impact the Company’s internal and external product portfolio and product approval process.
- Conduct knowledge sharing sessions as needed.
About Company
Regulatory Affairs Associate is responsible for the timely preparation and submission of adequate and accurate ANDAs and supplements in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. The role may involve responsibility for oral solids (tablets, capsules) or sterile liquids dosage forms for the R&D pipeline, as well as marketed products. The associate evaluates the quality and content of dossiers to ensure fast product approval.
Position Name :
CMC Regulatory Associate
Organization :
Endo Pharma
Qualification:
M.Pharm
Experience:
1 Year
Salary:
25,000 - 35,000 /month
Location:
India