Define and drive the global lifecycle regulatory strategy aligned with corporate, portfolio, and product objectives
Act as a strategic partner to senior leadership, communicating risks, opportunities, and regulatory scenarios
Lead, coach, and develop a high-performing global regulatory team
Oversee all post-approval regulatory activities, including variations, renewals, and regulatory commitments
Lead regulatory strategy for post-approval changes, including impact assessment, pathway optimization, and risk mitigation
Ensure compliance with global regulatory requirements and evolving health authority expectations
Partner with RA-CMC to align regulatory strategies for technical and manufacturing changes
Ensure timely, high-quality execution of lifecycle submissions through effective planning, tracking, and team accountability

Bachelor’s or advanced degree in Life Sciences, Pharmacy, Chemistry, or related field
7+ years of regulatory affairs experience with strong focus on post-approval lifecycle management
Proven experience working in cross-functional global environments
Leadership experience managing teams
Strong strategic, communication, and stakeholder management skills

Director, Regulatory Affairs – Market Products, Radiopharma

Key skills