Location: Amsterdam, the Netherlands (hybrid - 2 days home office)
Contract type: Permanent
We are seeking an experienced Senior Manager Regulatory Affairs to lead European regulatory activities for a portfolio of branded, innovative pharmaceutical products. You will be the single point of accountability for regulatory strategy and submissions, ensuring alignment with Target Product Profiles (TPPs) and business objectives, while driving high-quality interactions with Health Authorities.
What you'll doLead EU (and potentially Australia/New Zealand) regulatory development & registration strategies for new products (MAAs, Scientific Advice, ODD, PIP, CTAs).
Provide strategic input into regulatory development programs, lifecycle management, and compliance activities.
Build strong relationships with Health Authorities, leveraging negotiation and influencing skills.
Guide and mentor junior RA staff and coordinate external consultants/service providers.
Support cross-functional teams (Commercial, Medical, Market Access, Quality, PV, Supply, Artwork) with regulatory insight.
Scientific degree (Pharmacy, Chemistry, Life Sciences; PhD a plus).
8-10+ years in EU Regulatory Affairs, with strong experience in MAAs, Scientific Advice, PIPs, ODDs.
Proven track record with branded/innovative products (NCEs, biologics, or both).
Strategic mindset with the ability to influence agencies and stakeholders.
Fluency in English (other EU language a plus).
Strong leadership, collaboration, and problem-solving skills.
Hybrid role: 2 days from home → save time, reduce commuting, and improve work-life balance.
Manager with non-micromanagement style → autonomy, freedom, and ownership of your work.
Opportunity to work on innovative NCEs, plus exposure to generics if desired → broaden scope and responsibility.
Contribute directly to products that improve patients' lives.