Senior Director Regulatory Affairs

Are you a seasoned regulatory leader with experience in early-stage drug development for oncology or cardiovascular products? Our client is looking for a Senior Director of Regulatory Affairs , to drive regulatory strategy and ensure compliance in drug development at every stage.

The company :

Clinical stage biotechnology company based in Germany. A collaborative, dynamic and fast-paced environment with a solid early-stage pipeline.

The Role :

As Senior Director of Regulatory Affairs, you will :

• Lead a small team of regulatory professionals and manage external vendors.
• Lead regulatory strategy for drug development programs, ensuring adherence to EU and FDA regulatory requirements.
• Oversee interactions with regulatory authorities (EMA, FDA, etc.), preparing and submitting dossiers and applications.
• Provide expert guidance on regulatory pathways, clinical trial approvals, and product registration.
• Collaborate cross-functionally with R&D, clinical, and commercial teams to drive regulatory success.

Your Profile :

• Leadership experience is required, but must have remained hands-on with regulatory tasks.
• Extensive experience in regulatory drug development within biotech or pharmaceutical industries.
• Proven track record of successful regulatory filings and approvals.
• Strong understanding of EU and FDA regulatory frameworks, with global exposure being a plus.
• Strategic thinker with excellent leadership and communication skills.