Senior Manager, Global Regulatory Strategy

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cdcqa

Job Purpose

Do you want to shape the regulatory journey of tomorrow's medicines — from first-in-human to market approval? Join Angelini Pharma and take the lead on regulatory strategy for some of our most exciting development pipeline projects, from early pre-clinical stages through to global registration

What you'll do
You'll be the regulatory backbone of cross-functional teams, driving strategy, submissions, and health authority interactions across key regions (EU, US, Japan and beyond) — ensuring our innovative products reach patients faster and compliantly.

Key Responsibilities
Design and execute global regulatory strategies for pipeline programs, aligned with company goals and international requirements
Provide regulatory input into R&D; programs from the earliest stages of development
Prepare, review and manage submissions — INDs, NDAs, MAAs — with precision and on time
Lead responses to health authority queries with scientifically sound, timely answers
Track evolving regulations (FDA, EMA, ICH) and translate them into actionable strategy
Partner with R&D;,



Clinical Development, CMC, Safety, Quality and Business teams to build integrated regulatory plans
Prepare briefing documents and support key health authority meetings
Review and approve Clinical Trial Applications (CTAs)
Contribute regulatory due diligence expertise to new asset acquisitions, helping shape the future pipeline
Champion compliance with SOPs and global standards, driving continuous improvement

Requirements
Graduated to degree level in Life Sciences, Pharmacy, or a related scientific field. On top of what we would expect:
5+ years of managerial experience in pharma, with a track record of successful product registrations in key regions (EU, US, Japan)
Strong command of regulatory submission and approval processes across major markets
Solid grounding in drug development and regulatory science, especially for early-stage assets
Experience leading submissions and approvals for innovative produc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cdcqa