Principal Regulatory Program Director - Devices and Combination Products

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.

At Roche, the culture encourages personal expression, open dialogue, and genuine connections, where people are valued, accepted and respected. Roche aims to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

The role joins a high-caliber Roche Pharma team that turns regulatory complexity into a competitive advantage across portfolio delivery, capability building, and global policy shaping. The team develops multi-molecule platform frameworks, enables technical practices, and upskills the broader CMC organization.

More than 100’000 employees across the globe are dedicated to advancing science and ensuring access to healthcare. Roche’s efforts result in more than 26 million people treated with its medicines and over 30 billion tests conducted using its Diagnostics products.

• 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%.

• Visionary and agile regulatory strategist who thrives in dynamic matrix environments; excels at holistic systems thinking and executive-level communication; and is a collaborative leader and mentor dedicated to building organizational capabilities, fostering trust, and driving a high-performance team culture.