Seeking a visionary regulatory strategist to architect and drive global regulatory strategy for drug-device combination products and novel gene/cell therapy delivery systems. Lead cross-functional teams, shape regulatory policy, and deliver senior-level consultation. Ideal for an experienced professional with deep expertise in pharmaceutical CMC regulatory affairs and a collaborative leadership style.
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.
Tasks
- 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.
Requirements
- 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.
- 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%.
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Über uns
Das Team
You will join a high-caliber team that turns regulatory complexity into a competitive advantage across portfolio delivery, capability building, and global policy shaping. The 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.