Job Title:  Senior Manager, Global Regulatory Strategy

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 products
• Comfort working in global, matrix, cross-functional environments
• Track record in project planning/allocation within matrix organizations
• Excellent communication, negotiation and problem-solving skills — you know how to influence across departments and priorities.

You are a confident, polished presenter and negotiator, comfortable engaging with stakeholders at all levels. You are fluent in English, both written and spoken, and communicate with clarity and professionalism in every interaction.

The salary for this role starts from 64.000€ gross per year, depending on experience and location. The offer is determined based on gender-neutral criteria, including relevant skills, competencies, and experience. 

Angelini Pharma is an Equal Opportunity Employer.

We believe that diversity is a huge value that contributes to individual and company success. We are committed to create and foster a diverse and inclusive environment.