Principal Regulatory Program Director - Devices and Combination Products

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.

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!