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 recent 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
Robust 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
✨ Collaborat

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