EU Director, Regulatory Affairs

About the role

As the EU Director of Regulatory Affairs you will join TFS HealthScience’s Clinical Development Services unit, working with multidisciplinary teams to shape regulatory strategies for drug, device and combination product programs across Europe and globally.

Key responsibilities

• Lead and support European and global regulatory strategy for business units and new RFPs in device, drug and combination product development.
• Provide regulatory support for EMA and national scientific advice meetings, including protocol assistance.
• Develop and maintain country regulatory and startup intelligence, and prepare regulatory documents.
• Lead activities such as Pediatric Investigation Plans, orphan designation and PRIME support.
• Collaborate with US regulatory teams to create global strategies and guide internal and external customers.
• Support bid‑defence meetings, capabilities presentations and new system setups for startup regulatory support.
• Contribute to process‑improvement initiatives and ensure compliance with SOPs, local laws and regulations.

Required profile

• Bachelor’s degree in life sciences or a related field.
• Minimum 9 years of experience in international regulatory strategy for multi‑national clinical trials, especially EU CTR and CTIS.
• Proven experience supporting European scientific advice, orphan designation and pediatric investigation plans.
• Experience with RFP preparation, budget reviews, capabilities and bid‑defence meetings for international customers.
• Ability to work in a fast‑paced environment with changing priorities.

What we offer

• Competitive compensation package.
• Comprehensive benefits.
• Opportunities for personal and professional growth in a collaborative environment.