Senior Regulatory Group Director

At 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 Position

A healthier future. Its 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. Thats 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 Are

You 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:

• Masters 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!

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.