Associate Director of Regulatory Affairs

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.