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Looking to advance your career in Regulatory Affairs in Biotechnology? Lupin is hiring an Executive โ Regulatory Affairs at its Pune Biotech facility. This opportunity is ideal for candidates with 2โ3 years of experience in biotech regulatory affairs, especially those skilled in CTD dossier preparation, CMC documentation, and regulatory submissions in India.
This role offers hands-on exposure to CLAA and SLA regulatory processes, making it highly relevant for professionals aiming to grow in biopharma regulatory compliance and submissions.
Key Responsibilities
- Prepare applications for licenses and regulatory approvals (CLAA & SLA)
- Compile and submit CTD/ACTD dossiers for regulatory filings
- Handle post-approval variations and respond to regulatory queries
- Review CMC (Chemistry, Manufacturing, and Controls) documents
- Collaborate with cross-functional teams for compliance inputs
- Manage submissions via regulatory online portals
- Ensure adherence to Indian regulatory guidelines for biotech products
Qualifications & Eligibility
Education
- Postgraduate degree in Biotechnology / Biochemistry
- Graduate degree in Biotechnology / Biopharmaceutics
Experience
- 2 to 3 years in a biotech regulatory affairs department
- Practical exposure to dossier preparation and regulatory submissions
Required Skills
- Strong knowledge of CTD/ACTD format
- Understanding of CMC documentation
- Familiarity with Indian regulatory authorities (CDSCO, CLAA, SLA)
- Attention to detail and documentation accuracy
- Experience with regulatory submission portals
Salary & Benefits
- Estimated Salary: โน5,50,000 โ โน8,00,000 per annum
- Opportunity to work with a leading biopharmaceutical company
- Exposure to end-to-end regulatory lifecycle
- Career growth in global regulatory affairs domain
Job Location
- Pune Biotech, Maharashtra, India
How to Apply
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