Senior Director Regulatory Affairs

Green Life Science; Stuttgart; Vor Ort; EUR 90.000 - 150.000; Vollzeit

Zusammenfassung

A clinical-stage biotechnology company in Germany seeks a Senior Director of Regulatory Affairs to lead and manage regulatory strategy and compliance for drug development programs. This pivotal role involves overseeing interactions with regulatory authorities, leading a team, and ensuring adherence to EU and FDA standards, fostering collaboration across departments.

Qualifikationen

• Leadership experience in a regulatory role.
• Hands-on involvement in regulatory tasks.
• Extensive experience in biotech or pharmaceuticals.
• Proven success in regulatory filings and approvals.

Aufgaben

• Lead regulatory strategy for drug development programs.
• Oversee interactions with regulatory authorities.
• Collaborate with cross-functional teams to ensure regulatory success.

Kenntnisse

Leadership

Regulatory Affairs

Communication

Strategic Thinking

Jobbeschreibung

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.