Senior Regulatory Group Director

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 260.000 - 380.000; Vollzeit

Zusammenfassung

Roche Basel, a leader in global healthcare, seeks a Senior Regulatory Group Director to drive end-to-end regulatory strategies across portfolios, ensuring timely approvals and compliant execution. You will shape policy, align cross-functional teams, and influence programs at the highest level.

In this role you will lead health authority interactions, mentor leaders, and propel regulatory science in a fast‑evolving environment, with travel up to 10% to partner sites and stakeholders.

Qualifikationen

• Master’s or Post Graduate Degree in life sciences.
• 15+ years in pharma/biotech with global CMC regulatory leadership.
• Deep expertise in global CMC regulatory landscapes and health authority interactions.
• Strong understanding of drug substance/product manufacturing and analytics.
• Experience leading global, cross-functional teams and executive stakeholder communication.
• Strategic use of Regulatory Information Management systems and digital tools.

Aufgaben

• Oversee end-to-end regulatory strategies at portfolio level.
• Define long-term vision across product portfolios and cross-functional initiatives.
• Enable self-managed teams through coaching and performance management.
• Align priorities with global leaders, plan resources and budgets.
• Stay abreast of developments to assess implications for programs.
• Lead health authority interactions and project submissions.
• Serve as a key contact for regulatory capability areas to drive efficiency.
• Communicate challenges and opportunities to employees.
• Remove organizational barriers to progress.

Kenntnisse

Global regulatory leadership

CMC regulatory knowledge

Strategic leadership

Cross-functional collaboration

Communication & presentation

Regulatory risk assessment

Regulatory Information Management

Ausbildung

Master’s or Postgraduate Degree in life sciences

Tools

Regulatory IT tools

Jobbeschreibung

## Senior Regulatory Group DirectorApplylocations: Baseltime type: Full timeposted on: Posted Todayjob requisition id: 202607-119197At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.### ### The PositionA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.In this Leadership position in Pharma Technical Regulatory (PTR) you will have a broad understanding of the regulatory landscape and apply your knowledge in the execution of deliverables aligned with our North Star. As a leader you are accountable for advocating and driving changes throughout the organization and supporting our people in an agile environment. You will have a thorough understanding of priorities and areas of high impact, connect the right people and resources with the right work and help the organization adapt to evolving regulatory requirements. You will inspire all of our people to boldly innovate, collaborate and create outcomes that matter for patients, stakeholders and the company.In the role of a Group Director you will oversee both Portfolio Leadership and People Leadership supporting / enabling teams and people within this operating model (PTR ecosystem) to deliver on overall business objectives.### The Opportunity* You will have oversight and full accountability for the development and implementation of end-to-end regulatory strategies and initiatives on a portfolio level.* You will define long-term vision and strategies across product portfolios and cross-functional initiatives (targeting innovation, operational excellence, and policy), ensuring transparency across squads and teams.* You will enable self-managed teams by serving as a visionary, architect, coach, and catalyst to the organization, taking responsibility for performance management, objective feedback, and regular development discussions.* You will work collaboratively at the global level with other leaders to align on priorities, drive resource planning and budgeting, and support strategic projects as needed.* You will stay abreast of internal and external developments and trends to maintain a current perspective of implications for all programs, driving internal and external awareness.* You will lead health authority interactions and submission reviews for assigned projects with an expanded scope, representing Technical Regulatory at multidisciplinary meetings.* You will be a key point of contact for one (or more) regulatory capability area(s) (e.g., CTA, NDA, LCM, data management, systems) to drive operational efficiency and excellence.* You will serve as the voice of the organization, build and maintain relationships with key internal stakeholders, and communicate challenges, opportunities, and initiatives to employees in a systematic manner.* You will anticipate and remove organizational barriers that impede forward action and progress.### Who You AreYou are a visionary, adaptable, and strategic leader who thrives in an agile, global ecosystem. You bring exceptional negotiation skills, foster a culture of continuous coaching and growth, and excel at translating complex regulatory landscapes into clear action while empowering self-managed teams to innovate boldly for patients.Furthermore, you possess the following qualifications and experience:* Master’s or Post Graduate Degree in life sciences* 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.This role requires travel up to 10%.Are you ready to lead, innovate, and make a meaningful difference for our patients? We are looking forward to your application – join us now and become part of our journey!