Group Leader in Technical Regulatory
On-siteBasel, Basel-City, Switzerland
Job Summary
Develop end-to-end regulatory strategies and initiatives across product portfolios, defining long-term vision and ensuring transparency within cross-functional squads. Lead health authority interactions and submission reviews for assigned projects, representing Technical Regulatory in multidisciplinary meetings while driving operational efficiency for specific capability areas. Enable self-managed teams by acting as a visionary and coach, managing performance discussions and removing organizational barriers to expedite forward action. Collaborate globally on resource planning, budgeting, and strategic projects to align priorities and support the PTR ecosystem in adapting to evolving regulatory requirements.
Required Qualifications
- Master's or Post Graduate Degree in life sciences
- 15 or more years of work experience in the pharmaceutical or biotechnology industry
- significant global CMC regulatory leadership experience across the full product life-cycle
- Deep expertise in global CMC regulatory landscapes
- hands-on experience in scenario planning
- balanced regulatory risk assessment
- a proven track record representing the company in health authority interactions
- influencing regulatory science
- Strong technical understanding of drug substance & drug product manufacturing
- Strong technical understanding of drug product analytics
- experience in Small and/or Large Molecules
- a solid grasp of drug development
- a solid grasp of commercialization processes
- a solid grasp of supply chain complexity
- a solid grasp of Pharmaceutical Quality Systems
- Proven track record of direct people management
- cross-functional, global team leadership
- excellent communication and presentation skills
- Strategic perspective on Regulatory Information Management systems
- digital tools to drive compliance, efficiency, and excellence across the regulatory ecosystem
- This role requires travel up to 10%
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