Specialist Regulatory Affairs - LCM Strategic Growth Products

? Mumbai (Andheri) | Hybrid

At ADVANZ PHARMA, we're on a mission to improve patients' lives by increasing access to specialty, hospital, and rare disease medicines. We're looking for a Specialist Regulatory Affairs - LCM Strategic Growth Products to join our growing Regulatory team.

What You'll Do

You'll play a key role in managing the lifecycle of strategic growth products, including Biosimilars, Innovative Medicines, and Specialty Generics, ensuring compliance, supply continuity, and successful post-approval execution.

Key responsibilities include:

✅ Leading post-approval regulatory activities (variations, renewals, labeling updates, commitments, shortages, and maintenance)

✅ Acting as Regulatory Lead for assigned molecules across global markets

✅ Partnering with Health Authorities and cross-functional teams to drive regulatory strategy and submissions

✅ Supporting new product introductions, market expansion, and product launches

✅ Contributing to Scientific Advice activities, inspection readiness, and regulatory due diligence for M&A; projects

✅ Driving continuous improvement and ensuring timely closure of CAPAs and compliance actions





What We're Looking For:

- Bachelor's/Master's degree in Life Sciences, Pharmacy, or related field
- Formal training in Regulatory Affairs
- 8-10 years' experience in Regulatory Affairs Lifecycle Management within EU/UK and other regulated markets
- Strong experience with Biosimilars, ideally in post-approval lifecycle activities
- Solid understanding of EU/UK regulatory procedures, ICH guidelines, and CMC requirements
- Excellent stakeholder management and communication skills
- A proactive, solution-oriented mindset with a passion for continuous improvement

Why ADVANZ PHARMA?

✨ Make a direct impact on patient access to medicines

✨ Work in a fast-growing international pharmaceutical company

✨ Hybrid and flexible working model

✨ Global recognition and wellbeing programs

✨ Cooperative culture built on Entrepreneurship, Speed, and Integrity

82% of our employees recommend ADVANZ PHARMA as a great place to work.

Ready to make an impact? Apply now.

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📌 Specialist Regulatory Affairs LCM- Biosimilars (Mumbai)
🏢 Advanz Pharma
📍 Mumbai