Must be based in Switzerland.

My client is seeking an experienced and driven Regulatory Expert to join their team for a full-time 12 month contract. This role is pivotal in ensuring regulatory compliance and clinical excellence across the product lifecycle, from clinical trial applications to post-approval activities. The ideal candidate will bring expertise in pediatrics, orphan, and rare diseases, along with proven experience leading the roll drugs internationally after approval.

Key Responsibilities:

Oversee the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) across EU and international markets. Lead regulatory activities related to Orphan Drug Designation (ODD), Pediatric Investigation Plans (PIP), and Scientific Advice procedures. Manage pre- and post-approval regulatory submissions and compliance activities. Provide strategic input for rolling out approved products internationally, ensuring adherence to global regulatory requirements. Collaborate with cross-functional teams to support clinical trial initiation (CTIs) and regulatory strategy development. Act as the regulatory lead for pediatric, orphan, and rare disease programs, ensuring alignment with applicable guidelines and frameworks. Maintain up-to-date knowledge of EU and international regulatory requirements, providing expertise and guidance to internal teams.

Qualifications:

5–8 years of experience in regulatory affairs and clinical operations within the biopharmaceutical industry. Demonstrated expertise with CTAs, ODD, PIP, Scientific Advice, and related regulatory processes. Proven experience in international drug rollout following product approval. In-depth knowledge of EU and global regulatory landscapes, with specific focus on pediatrics, orphan, and rare diseases. Exceptional communication and interpersonal skills for cross-functional collaboration and external stakeholder engagement. Strong organizational and problem-solving abilities with a detail-oriented approach.

Preferred Experience:

Hands-on involvement in end-to-end product lifecycle management. Prior experience engaging with regulatory authorities (e.g., EMA, FDA). Familiarity with CTIS. 

To be considered for this role, candidates must meet all qualifications listed above. Interested applicants can submit their CV via email to nashley@barringtonjames.com or contact us at +441293 776644 for a discussion.

While we appreciate all applications, we may not be able to respond to every submission due to the high volume of candidates.