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 rapid-growing international pharmaceutical company