Exciting opportunity for a Regulatory Affairs Sr. Associate (CMC) in Digha! Manage USFDA submissions, ANDAs, and compliance. M.Pharma (Pharmaceutics) with 3-5 yrs exp. Apply now
A leading pharmaceutical company committed to innovation and compliance, specializing in generic drug development and regulatory submissions to global health authorities like the USFDA. The company fosters a collaborative work environment with a strong focus on quality and regulatory excellence.
Detailed Job Description
Position: Sr. Associate – Regulatory Affairs (CMC)
Location: Digha, India
Job Type: Full-time
Posted: Recently
Requisition ID: R002510
Key Responsibilities:
- Prepare, compile, and submit ANDA filings, amendments, and supplements to the USFDA.
- Handle deficiency responses and ensure timely submissions.
- Coordinate with cross-functional teams (R&D, Quality, Manufacturing, SCM, IP, PM) and vendors for regulatory compliance.
- Review critical documents including:
- Product Development Reports
- Batch Records (Executed & Intended)
- Specifications, Analytical Procedures, Method Validation Reports
- Stability Protocols & Reports
- Vendor documents (API, Excipients, Packaging Materials)
- Ensure submissions are in eCTD format and compliant with FDA requirements.
- Monitor FDA website updates for regulatory changes.
Eligibility & Qualifications:
- Education:Â M.Pharma (Pharmaceutics)
- Experience:Â 3-5 years in Regulatory Affairs (CMC), specifically in USFDA submissions.
- Skills Required:
- Strong knowledge of ANDA filings, eCTD submissions, and ICH guidelines.
- Expertise in document review and regulatory compliance.
- Excellent coordination and communication skills.
Benefits & Perks:
- Competitive salary & performance incentives.
- Career growth in a global pharmaceutical regulatory environment.
- Work with industry experts in drug development and compliance.
- Health benefits and flexible work policies.
