Regulatory Affairs Director

May 28, 2025

we are looking for...

Regulatory Affairs Director

Contracting

Ref: BH-2211-4

Regulatory Affairs Director

Job details

Contracting

Ref: BH-2211-4

Website headcount

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
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