Must be able to be onsite 2 days per week in Switzerland.

My client is seeking an experienced and driven Regulatory Expert to join their team for a full-time contract until end of 2025. This role is pivotal in ensuring their clinical programme is accelerated as well as managing their commercially approved product. The ideal candidate will bring expertise in clinical trials, the new CTIS, Rare Disease/Orphan indications for European, US and Global markets.

Key Responsibilities

• Oversee the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) using CTIS.
• Lead regulatory activities related to Orphan Drug Designation (ODD), Pediatric Investigation Plans (PIP) and Scientific Advice procedures.
• Lead the preparation and critical review of submission documents to ensure compliance of regulatory requirements (EU and International)
• Provide strategic input for rolling out approved products internationally, ensuring adherence to global regulatory requirements.
• Contributes to and reviews responses to global health authority questions to ensure consistent and complete answers aligned with global strategy
  
  

Qualifications

• 10 + years of experience in regulatory affairs within the biopharmaceutical industry (rare/orphan portfolio's)
• Experience with major health authorities (EMA, FDA, International)
• Demonstrated expertise with Clinical Trials (familiarity with CTIS is preferred)
• Experience with regulatory submissions (MAA/NDA), ODD's, PIP's and post-approval activities
• Strong interpersonal, communication and problem-solving abilities with a detail-oriented approach.
• Hands-on involvement in end-to-end product lifecycle management.