Principal Regulatory Program Director - Devices and Combination Products

About the role

Roche Pharma is looking for a Principal Regulatory Program Director for devices and combination products in Basel. The role sits in a team that turns regulatory complexity into a competitive advantage, shaping global regulatory policy and upskilling the CMC regulatory organization. The position may be hired at the Senior Regulatory Program Director level depending on background and experience.

Key responsibilities

• 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 regulatory domains across technical device lifecycle management, pharma CMC drug frameworks and clinical device domains.
• Champion scalable, portfolio-enabling device platform strategies that shorten development timelines.
• Partner with Pharma Technical, Pharma Development, Global Pharma Procurement/Supply, Research & Early Development and Roche Diagnostics.
• Provide risk management, regulatory guidance and senior-level device regulatory consultation aligned with global health authority expectations.
• Represent Roche in external policy venues and engage directly with global Health Authorities.
• Author and share external positions through trade groups, international working groups, industry presentations and publications.
• Build internal device regulatory capabilities and improve operating models, processes and systems.

Required profile

• 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 in the biopharmaceutical/medical device industry.
• Extensive global regulatory strategy expertise in drug-device combination products and pharmaceutical/biologic CMC frameworks across the full product lifecycle.
• Proven track record of health authority interactions, negotiations and major global drug approvals.
• Demonstrated experience building relationships with global regulators, health authorities and trade associations.
• Willingness to travel up to 10%.