Global Head of Regulatory Affairs, Roche Diagnostics

About the role

Roche Diagnostics is looking for a visionary, scientifically credible leader to become Global Head of Regulatory Affairs. The role facilitates product registrations of the company's pipeline so that diagnostic solutions reach customers and patients worldwide. It sits in the Global Quality, Regulatory and External Affairs leadership team and represents the global function on the Roche Diagnostics Solutions Leadership Team.

Key responsibilities

• Provide strategic direction for global regulatory submissions and lead teams in Europe, the US and APAC
• Act as regulatory contact with the US FDA, international regulatory agencies, other regulatory bodies and affiliates
• Work with affiliates to ensure timely registration data and dossiers, and monitor global regulatory environments
• Develop best-in-class regulatory processes, practices and submission strategies, and drive process standardization and reuse
• Own the product registration strategy, RA resource allocation and performance management, and QMS modules for registration including IT systems
• Ensure on-time delivery of registrations to lifecycle teams and commercial affiliates, and grow the technical capabilities of the RA team
• Lead the RA team, mentor others and foster an agile mindset focused on high-quality submissions

Required profile

• 15+ years of progressively responsible regulatory management experience, preferably in international and US arenas
• Experience in diagnostics or medtech, with a proven track record of filings (510(k)s, PMAs, IDEs, global dossiers) and direct negotiations with the US FDA and global regulators
• 5-7 years leading teams and managing budgets
• University degree in a relevant field; post-graduate qualifications such as MSc, MBA or higher preferred
• Proven experience building and leading diverse, global teams and matrix leadership of enterprise-level technology projects
• International business travel required depending on location and project needs

Required skills

• Strong stakeholder management and negotiation in a matrixed organization
• VACC leadership style (visionary, architect, coach, catalyst) and mentoring
• Strategic, analytical and innovative thinking, with strong communication and independent influence