Looking for Regulatory Affairs Biologics jobs in India? Here’s a high-impact opportunity with Amneal Pharmaceuticals for experienced professionals in biosimilars and biologics regulatory affairs.
Amneal is actively hiring candidates with expertise in USFDA, EMA submissions, biosimilar pathways, and CMC for biologics. This role offers end-to-end exposure across development, global submissions, and lifecycle management for large molecule products.
If you have experience in regulatory affairs biologics, eCTD submissions, and biosimilars strategy, this opportunity in Ahmedabad can significantly accelerate your regulatory career.
📌 Job Overview
- Company: Amneal Pharmaceuticals
- Role: Regulatory Affairs – Biologics/Biosimilars
- Location: Ahmedabad, Gujarat, India
- Experience: 3–10 Years
- Qualification: M.Pharm / MSc / PhD (Biotechnology / Life Sciences)
- Job Type: Full-Time
🔬 Key Responsibilities – Regulatory Affairs Biologics
- Preparation and submission of global regulatory dossiers (CTD/eCTD)
- Managing IND, BLA, ANDA, IMPD, MAA submissions
- Developing regulatory strategy for biologics and biosimilars
- Handling regulatory queries, deficiency responses, and agency interactions
- Managing post-approval changes and lifecycle activities
- Supporting regulatory inspections and audit readiness
- Collaborating with R&D, QA, Manufacturing, Clinical, and Pharmacovigilance teams
🧪 Required Skills & Expertise
- Strong experience in Regulatory Affairs Biologics/Biosimilars
- Knowledge of USFDA 351(k) pathway and EMA biosimilar guidelines
- Expertise in CMC for biologics:
- Cell line development
- Upstream & downstream processing
- Analytical characterization
- Validation & comparability studies
- Hands-on experience in eCTD submissions
- Experience in sterile/injectable or specialty biologics (preferred)
🎓 Qualifications
- M.Pharm / MSc / PhD in Biotechnology, Life Sciences, or related field
- 3–10 years of experience in Regulatory Affairs (Biologics/Biosimilars)
💰 Salary & Benefits
- Estimated Salary: ₹8 LPA – ₹22 LPA (based on experience & expertise)
- Opportunity to work on global regulatory submissions (US & EU markets)
- Exposure to advanced biologics and biosimilar development programs
- Strong cross-functional learning environment
- Career growth in global regulatory affairs and compliance
📩 How to Apply
Interested candidates can apply by sharing their updated CV:
📧 Email: Nandini.Nair@amneal.com
📌 Mention relevant experience in biologics regulatory affairs in subject line