Principal Regulatory Program Director - Devices and Combination Products

Roche; Penzberg; Presencial; EUR 247.000 - 322.000; Jornada completa

Descripción de la vacante

Roche Pharma seeks a Principal Regulatory Program Director to lead global regulatory strategy for complex drug-device technologies and standalone devices. You will align cross-functional teams, shape external policy, and advance device regulatory capabilities across the organization.

You will collaborate with Pharma Technical, Development, and Roche Diagnostics to drive regulatory excellence, while engaging health authorities to ensure approvals and market access.

Formación

• Bachelor's degree in engineering, or a related scientific discipline (advanced degree preferred).
• Minimum 15 years of experience in regulatory affairs, drug development, or technical development within the biopharmaceutical/medical device industry.
• Primary focus and extensive global regulatory strategy expertise in drug-device combination products and pharmaceutical/biologic CMC frameworks across the full product lifecycle.
• Proven track record of successful health authority interactions, negotiations, and major global drug approvals.
• Demonstrated experience building trusted relationships with global regulators, health authorities, and trade associations to shape external regulatory policies.
• Willingness and ability to travel up to 10%.

Responsabilidades

• Architect and drive global regulatory strategy for complex technologies, including drug-device combinations, novel gene/cell therapy delivery systems, and standalone physical devices.
• Champion scalable, portfolio-enabling device platform strategies that accelerate development timelines and drive efficiency across multiple pipeline molecules.
• Partner closely with key internal stakeholders across Pharma Technical, Pharma Development, Global Pharma Procurement/Supply, Research & Early Development, and Roche Diagnostics.
• Provide strategic risk management, regulatory guidance, and high-level decision-making to solve high-impact challenges in alignment with business objectives.
• Deliver senior-level device regulatory consultation to ensure alignment with global health authority expectations.
• Represent Roche Pharma in key external policy venues, engaging directly with global Health Authorities to shape regulatory policy and industry standards.
• Author and disseminate strategic external positions through trade groups, international working groups, industry presentations, and publications.
• Build internal device regulatory capabilities and evolve operating models, processes, and systems to support rapid device innovation.

Conocimientos

Regulatory strategy

Health authority negotiations

Cross-functional leadership

Regulatory policy shaping

Educación

Bachelor's degree in engineering or related scientific discipline

Descripción del empleo

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

As a Principal Regulatory Program Director at Roche Pharma, you will join a high-caliber team that turns regulatory complexity into a competitive advantage across portfolio delivery, capability building, and global policy shaping. Recognized internally and externally for your deep device regulatory mastery, pharmaceutical CMC regulatory experience, and clinical domain knowledge (such as PK/BE bridging), you will serve as a strategic steward across disciplines. Beyond driving core execution, our team architects pioneering, multi-molecule platform frameworks, enables best-in-class technical practices, and upskills the broader CMC organization—transforming how device technology reaches patients worldwide.

The Opportunity

Are you passionate about not only driving high-impact portfolio strategies, but also fostering a collaborative organizational culture that empowers connected teams to deliver their best work? Do you want to directly shape global regulatory policy while upskilling an entire CMC regulatory organization?

• Architect and drive global regulatory strategy for complex technologies, including drug-device combination products, novel gene/cell therapy delivery systems, and standalone physical devices. Integrate multi-disciplinary regulatory domains across technical device lifecycle management, pharma CMC drug frameworks, and clinical device domains to ensure seamless execution of the regulatory strategy.
• Champion scalable, portfolio-enabling device platform strategies that accelerate development timelines and drive efficiency across multiple pipeline molecules
• Partner closely with key internal stakeholders across Pharma Technical, Pharma Development, Global Pharma Procurement/Supply, Research & Early Development, and Roche Diagnostics
• Provide strategic risk management, regulatory guidance, and high-level decision-making to solve high-impact challenges in alignment with business objectives. Deliver senior-level device regulatory consultation to ensure alignment with global health authority expectations
• Represent Roche Pharma in key external policy venues, engaging directly with global Health Authorities to shape regulatory policy and industry standards
• Author and disseminate strategic external positions through trade groups, international working groups, industry presentations, and publications
• Build internal device regulatory capabilities and evolve operating models, processes, and systems to support rapid device innovation

Who You Are

You are a visionary and agile regulatory strategist who thrives in dynamic matrix environments. You excel at applying holistic systems thinking to navigate complex, ambiguous regulatory landscapes and possess executive-level communication skills to align senior leaders and cross-functional partners. As a collaborative leader and mentor, you are dedicated to building organizational capabilities, fostering trust, and driving a high-performance team culture.

Qualifications

• Bachelor's degree in engineering, or a related scientific discipline (advanced degree is preferred)
• Minimum 15 years of experience in regulatory affairs, drug development, or technical development within the biopharmaceutical/medical device industry
• Primary focus and extensive global regulatory strategy expertise in drug-device combination products and pharmaceutical/biologic CMC frameworks across the full product lifecycle
• Proven track record of successful health authority interactions, negotiations, and major global drug approvals
• Demonstrated experience building trusted relationships with global regulators, health authorities, and trade associations to shape external regulatory policies
• Willingness and ability to travel up to 10%

Note

Depending on your background and experience, the level of the position may be hired at the Senior Regulatory Program Director level.

Where pay transparency applies

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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.