Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die 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.

Further, you possess the following qualifications and experience:

• 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.

Are you ready to make a difference for our patients? We are looking forward to your application – join us now and become part of our journey!

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.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.