Regulatory Scientist

Exciting Opportunity: Regulatory Scientist – Early Development (Europe) Are you a scientifically curious, hands-on regulatory professional looking to make an impact in early-stage drug development? We are seeking a Regulatory Scientist to join a dynamic global team supporting innovative therapies in rare diseases and biologics . What You’ll Do: Support the development and execution of global and regional regulatory strategies for early development programs. Contribute to submissions such as INDs/CTAs, MAAs, briefing documents, and regulatory reports. Provide regulatory input for inspections, audits, product complaints, and post-approval maintenance. Collaborate with cross-functional teams to integrate scientific insights into regulatory planning. Bring innovation and creativity to problem-solving and regulatory strategy development. Who You Are: Scientist at heart : University degree in biomedical or scientific field. Experienced : 3+ years in a clinical development or regulatory environment, ideally with first-in-human experience . Global-minded : Exposure to EMA, FDA, and/or JAPAC regulations. Analytical and strategic : Able to assess diverse molecules and translate insights into actionable strategies. Independent and proactive : Comfortable taking ownership, co-creating solutions, and working in an empowered way. Strong interpersonal skills, flexible, and collaborative mindset. Why This Role? Contribute directly to the development of innovative therapies in rare diseases and biologics . Work in a highly empowered, collaborative environment that values creativity and initiative. Flexible European location with occasional office presence. #J-18808-Ljbffr