Your role

• Serve as Regulatory Affairs expert for early-stage development projects within the radiopharmaceutical pipeline, with a primary focus on upcoming IND/CTA submissions, reporting directly to the Head of Clinical Regulatory Affairs
• Act as the primary regulatory contact with key Health Authorities (FDA, EMA), holding operational accountability for regulatory interactions and submissions in close collaboration with subject matter experts and the Global Project Team (GPT)
• Lead the preparation and conduct of scientific Health Authority meetings (Pre-IND, Type A–D, EMA Scientific Advice, Protocol Assistance) and oversee timely preparation, submission, and approval of original and amendment filings (INDs, CTAs) in the US, EU, and other regions
• Develop and implement global regulatory strategies for assigned product candidates in alignment with the clinical development plan and overall program objectives
• Plan, organize, and manage regulatory activities in line with global development plans and regulatory milestones, including identification of risks and implementation of mitigation strategies for complex radiopharmaceutical products
• Coordinate timely, high-quality responses to Health Authority requests and ensure the use of appropriate regulatory pathways to optimize submission strategies
• Provide regulatory input, review, and approval of key clinical and non-clinical documents, including study protocols, Investigator’s Brochure (IB), Clinical Study Reports (CSR), and non-clinical reports
• Author and review high-quality, product-specific regulatory documents (e.g., meeting requests, briefing books, iPSPs, orphan annual reports) in close collaboration with cross-functional experts, ensuring compliance with regional regulatory requirements
• Provide clear, proactive regulatory guidance to clinical trial teams using an “out-of-the-box” mindset, maintain strong cross-functional stakeholder collaboration, stay current with evolving regulatory guidelines, and support non-program-specific initiatives (e.g., business development, departmental projects, training)