Global Regulatory Lead

Join Idorsia as a Global Regulatory Lead to develop and execute regulatory strategies in Europe and other regions, represent Global Regulatory Affairs for assigned products, and collaborate with key stakeholders across labeling, safety, commercial, and affiliate teams.

Requirements

• Master's Degree in life sciences
• At least 5 years of regulatory experience or other job relevant drug development experience
• Leading/delivering global and/or regional filings
• Reviews and approvals of major submissions to Health Authorities (HAs)
• Leading HA interactions
• In-depth knowledge of regulatory legislation and guidelines (ICH, US and EU) and good understanding of other regions
• Strong understanding of the regulatory aspects at various stages of development, from entry-into-man to post-approval activities over full lifecycle of products
• In-depth experience working, communicating and negotiating with the HAs, including coordinating and managing HA meetings
• Strong scientific competence and familiarity with clinical trial methodology and statistics
• Proven development experience
• Proven experience as successful leader in strategic cross-functional environment and matrix environment
• Excellent communication, interpersonal, negotiation and problem-solving skills
• Very good understanding of interrelationships between functions, departments and business priorities
• Effective team player, with experience working in cross-functional and global teams, but also able to work independently
• Ability to work within tight timelines with excellent project management skills
• Excellent spoken and written English

Benefits

• Development – opportunities to grow, learn, and expand your expertise in a dynamic and international organization
• A collaborative culture – a supportive, solution-oriented environment where teamwork, initiative, and new ideas are encouraged
• International exposure – work in a truly multicultural setting with colleagues and partners from around the world