Looking for Regulatory Affairs jobs in Mumbai? Here’s a high-impact opportunity at Lupin Ltd, one of India’s leading pharmaceutical companies.
Lupin is hiring an Executive – Regulatory Affairs (US ANDA) role in Airoli, Mumbai. This position is ideal for candidates with 2–3 years of experience in USFDA ANDA submissions, particularly in Oral Solid Dosage (OSD).
If you are aiming to build a career in US regulatory affairs, ANDA submissions, lifecycle management, and global compliance, this role offers strong exposure to regulated markets and real-time regulatory strategy.
📌 Job Details
- Position: Executive – Regulatory Affairs (US ANDA)
- Company: Lupin Ltd
- Location: Airoli, Mumbai, Maharashtra
- Experience: 2–3 Years
- Qualification: B.Pharm / Pharmacy Graduate
- Job Type: Full-Time
🔍 Key Responsibilities – Regulatory Affairs (US ANDA)
- Lead ANDA regulatory submissions for Oral Solid Dosage (OSD) products in the US market
- Prepare and submit responses to USFDA deficiency letters
- Manage post-approval submissions, supplements, and annual reports
- Handle labeling updates as per Reference Listed Drug (RLD) changes
- Support PADER reporting for pharmacovigilance compliance
- Review regulatory documents during development, scale-up, and commercialization
- Ensure compliance for externally manufactured products
- Collaborate with cross-functional teams including QA, QC, and Manufacturing
🎓 Qualifications & Skills
- Bachelor’s degree in Pharmacy (B.Pharm / M.Pharm preferred)
- 2–3 years experience in US ANDA regulatory submissions
- Strong knowledge of:
- USFDA guidelines & eCTD submissions
- CMC documentation (Module 3)
- Lifecycle management & variations
- Familiarity with PADER, labeling updates, and deficiency responses
- Key competencies:
- Strategic agility
- Regulatory compliance mindset
- Stakeholder management
- Process excellence
💰 Salary & Benefits
- Estimated Salary: ₹4.5 LPA – ₹7.5 LPA (based on industry standards)
- Opportunity to work on global USFDA projects
- Exposure to regulated markets (US)
- Career growth in Regulatory Affairs & Global Submissions
- Collaborative and innovation-driven work culture
🚀 Why This Role is Important
With increasing demand for US generic drug approvals, Regulatory Affairs professionals with ANDA experience are highly valued. This role strengthens your expertise in:
- USFDA submissions
- Global regulatory strategy
- Pharma lifecycle management
Perfect for candidates targeting Regulatory Affairs Manager / CMC Specialist roles in the future.
📩 How to Apply
