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. 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), gaining a broad understanding of the regulatory landscape and applying your knowledge in executing deliverables aligned with our North Star. You are accountable for advocating and driving changes throughout the organization and supporting our people in an agile environment. With a thorough understanding of priorities and areas of high impact, you will connect the right people and resources with the right work, helping the organization adapt to evolving regulatory requirements. You will inspire all our people to boldly innovate, collaborate, and create outcomes that matter for patients, stakeholders, and the company.

To maintain our License to Operate in a highly regulated industry, you must ensure GxP compliance and adhere to the Roche Group Code of Conduct as part of your responsibility. This includes obtaining the appropriate training, experience, and qualifications necessary to perform and complete your work in accordance with regulatory requirements, corporate policies, and standards.

As a Group Director, you will support and enable teams and people within this operating model—our PTR ecosystem—to deliver on their business objectives, encompassing both Portfolio Leadership and People Leadership.

The Opportunity:

• You will develop and implement end-to-end regulatory strategies and initiatives at a portfolio level, ensuring transparency, prioritization, resource planning, budgeting, and long-term vision.
• You will stay abreast of internal and external developments and trends, driving awareness of implications for all programs both internally and externally.
• You will collaborate globally with other leaders to align on priorities and support organizational goals, involving prioritization to support projects and initiatives as needed.
• You will lead health authority interactions and submission reviews for assigned projects, representing Technical Regulatory at multidisciplinary meetings with health authorities.
• You will translate business and customer needs into priorities for the Community or Function, guiding the focus of squads and teams, and drive efficiency and excellence in regulatory capabilities.
• You will build and maintain relationships with key internal stakeholders, advocating internally and externally, and removing organizational barriers to progress.
• You will enable self-managed teams, promote a culture of continuous growth and learning, and communicate and inspire connection and excitement with the North Star, forming diverse and inclusive teams to achieve high impact results.

Who you are

• You will have a Bachelor’s degree, with a strong preference for scientific focus or equivalent industry experience. You will also bring 15 or more years of work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory, or related experience.
• You will bring proven knowledge of relevant global Health Authority guidelines and experience in interacting with health authorities. In addition, you would have solid experience developing regulatory strategies and scenario planning with robust regulatory risk assessment.
• You will bring technical understanding of drug substance and product manufacturing, in one or both modalities Small Molecule and LM and product development processes, as appropriate.
• You will have understanding of drug development, commercialization process, supply chain complexity and Pharmaceutical Quality Systems and knowledge of multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.
• You will have a proven track record of team leadership, preferably cross-functional teams and ability to develop people through mentoring
• You will bring excellent communication and presentation skills and be able to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making.

Preferred:

• Master’s Degree in life science disciplines is strongly preferred; Post Graduate Degree is a plus.
• Previous People management or cross-functional team leadership experience is desired

Travel Requirements:

Ability to travel up to 20%

Relocation benefits not available for this position

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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