Job Posting: CMC Regulatory Associate at Endo Pharma
About Company:
Endo Pharma is seeking a dedicated Regulatory Affairs Associate to prepare and submit accurate ANDAs and supplements in eCTD format. This role involves collaboration with various stakeholders to ensure timely approvals for oral solids (tablets, capsules) or sterile liquids in our R&D pipeline and marketed products.
Position:
CMC Regulatory Associate
Organization:
Endo Pharma
Qualifications:
M.Pharm
Experience:
1 Year
Salary:
₹25,000 – ₹35,000 /month
Location:
India
Job Responsibilities:
- Collate and review CMC documents:
- Master Formula Card
- PDR
- BMR
- BPR
- Specifications
- Validation reports
- Departments involved:
- F&D
- ADL
- QA
- Production
- Packaging
- Review data for:
- ANDA preparation
- Deficiency responses
- Annual reports
- Supplements
- Prepare and review ANDA sections.
- Compile controlled correspondences:
- Excipients
- Q1/Q2 queries
- BE guidance
- General queries to the FDA
- Assist in developing and implementing regulatory strategies to address complex issues impacting product portfolio and approval process.
- Conduct knowledge-sharing sessions as needed.
Meta Description:
Join Endo Pharma as a CMC Regulatory Associate. M.Pharm required, 1 year experience, salary ₹25k-₹35k/month. Apply now!