About the job
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.
Ready to make a difference? Reach out to me at rhi@greenlsr.com