Global Regulatory Strategy Director

Roche; Basel; Vor Ort; CHF 300.000 - 480.000; Vollzeit

Zusammenfassung

Roche is seeking a Group Director in Pharma Technical Regulatory (PTR) to lead end-to-end regulatory strategies across product portfolios on a global scale. You will advocate, drive changes, and align resources with leaders to deliver outcomes that matter for patients and stakeholders.

You will oversee health authority interactions, build cross-functional partnerships, and mentor teams to navigate evolving regulatory requirements while sustaining performance in an agile environment.

Qualifikationen

• 15 or more years of work experience in the pharmaceutical or biotechnology industry, with 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, and a proven track record representing the company in health authority interactions and influencing regulatory science.
• Strong technical understanding of drug substance & drug product manufacturing and analytics in Small and/or Large Molecules, alongside a solid grasp of drug development, commercialization processes, supply chain complexity, and Pharmaceutical Quality Systems.
• Proven track record of direct people management and cross-functional, global team leadership, with excellent communication and presentation skills to synthesize complex issues and expedite executive decision-making.
• Strategic perspective on Regulatory Information Management systems and digital tools to drive compliance, efficiency, and excellence across the regulatory ecosystem.

Aufgaben

• Oversee the development and implementation of end-to-end regulatory strategies and initiatives on a portfolio level.
• Define long-term vision and strategies across product portfolios and cross-functional initiatives.
• Enable self-managed teams by serving as a visionary, architect, coach, and catalyst to the organization.
• Collaborate at the global level with other leaders to align on priorities, drive resource planning and budgeting.
• Stay abreast of internal and external developments and trends to maintain a current perspective for all programs.

Ausbildung

Master's or Post Graduate Degree in life sciences

Jobbeschreibung

Roche is seeking a Group Director in Pharma Technical Regulatory (PTR) to lead end-to-end regulatory strategies across product portfolios on a global scale. You will advocate, drive changes, and align resources with leaders to deliver outcomes that matter for patients and stakeholders.

You will oversee health authority interactions, build cross-functional partnerships, and mentor teams to navigate evolving regulatory requirements while sustaining performance in an agile environment.