Regulatory Affairs Director 

Location: Switzerland, Netherlands, Ireland, German OR UK
Contract: 12-month contract
Start Date: ASAP
Workload: 100%

Our client is looking for an experienced Regulatory Affairs professional to support their International Regulatory team as a contractor at Associate Director or Director level. You will play a key role in leading EU and national MAA submissions and supporting broader international regulatory activities. This is a great opportunity to work cross-functionally in a dynamic and fast-paced biotech environment with a strong pipeline.

Your Tasks:

• Lead the preparation, submission, and maintenance of EU and national Marketing Authorization Applications (MAAs)
• Act as the primary point of contact with EMA and national competent authorities, including direct negotiations and meeting management
• Develop and implement regulatory strategies for clinical trials and market approvals in collaboration with the Global Regulatory Lead
• Provide strategic input into regulatory documents including briefing packages, clinical protocols, and post-approval changes
• Offer expert guidance on EU regulatory pathways including orphan designation and PRIME
  Ensure alignment of global regulatory strategies with EU and international requirements
• Collaborate with cross-functional teams including Clinical, Medical Affairs, and Commercial
• Support early access and compassionate use programs in coordination with Medical Affairs
• Monitor regulatory trends and assess their impact on business strategy
• Engage with commercial partners in regions without direct presence

Your Profile:

• Minimum 8 years’ experience in Regulatory Affairs within pharma or biotech
• Deep understanding of EU regulatory procedures and international requirements
  Proven experience with successful MAA submissions and regulatory authority interactions
• Bachelor’s or advanced degree in Life Sciences

Please apply directly online with your CV.
Please only apply if you are eligible to work in Switzerland and the EU
headcount AG