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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.

Roche Pharma Global Technical Operations for Cell and Gene Therapies (PTC) delivers a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges as the Regulatory landscape is evolving very quickly.

In this key leadership position as the Global Head of PTC Regulatory you are accountable for the quality of all Regulatory Applications including initial global Marketing Authorizations for Roche`s CGT portfolio. You are accountable for all interactions with global Health Authorities related to CMC aspects and are expected to be an inspiring leader in the industry helping to shape the regulatory environment and to develop innovative concepts in support of Roche`s CGT portfolio.

As a member of the Roche PTC Leadership Team, you play a key role in developing, shaping and implementing the overall technical strategy of our company in the Cell & Gene Therapy space.

The Global Head of PTCR has a broad understanding of the regulatory landscape for Cell & Gene Therapy (CGT) products. Given the complexity of CGT products and their manufacturing processes, as well as an evolving global regulatory framework, it’s necessary to be agile and thoughtful in applying the current regulatory guidelines.

Your opportunity

• Regulatory Strategy Development: Oversee and implement end-to-end regulatory strategies for the ATMP portfolio and support development and product supply teams.

• Stakeholder Collaboration: Build and maintain relationships with key internal stakeholders and collaborate with internal and external partners.

• Health Authority Interactions: Lead interactions with global Health Authorities, including conference committees and multidisciplinary meetings.

• Policy and Advocacy : Lead internal policy groups, collaborate with industry associations, and act as an external spokesperson to shape the regulatory environment for ATMPs.

• Leadership and Development: Lead a global organization, ensure strategic talent resourcing, provide training on global guidelines, and foster the development of SMEs in regulatory strategy.

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Who You Are

You are an accomplished leader with a robust background in Technical Regulatory and Technical Development of Cell and Gene Therapies (CGTs). Your qualifications and experiences make you a perfect fit for this pivotal role:

• Educational Background: You hold a PhD in a relevant technical area, complemented by over 15 years of experience in Regulatory, Quality, Process Development, or Manufacturing within the biopharmaceutical industry.

• Leadership Experience : You bring senior leadership experience from the biotechnology or pharmaceutical sectors. Your leadership style is visionary, architect, coach, and catalyst (VACC), and you have a proven track record of passionately advocating these principles.

• Interpersonal Skills : Your ability to navigate and excel in a complex, global, and highly matrixed environment is noteworthy. You possess the interpersonal skills necessary to foster collaboration and drive success across diverse teams.

• Business Acumen : You are a strategic thinker with strong business acumen. Your insights and decisions are informed by a deep understanding of the industry and its regulatory landscape.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.