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.
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