Strategic Regulatory Director: Drug-Device Combos

Roche; Basel; On-site; CHF 250,000 - 360,000; Full time

Job summary

Roche seeks a Principal Regulatory Program Director to architect and drive global regulatory strategy for complex drug-device technologies. You will integrate device and pharma regulatory domains, shaping policy while aligning with Roche's strategic objectives.

The role emphasizes leadership, cross-functional collaboration, and stakeholder engagement to accelerate development timelines and ensure regulatory excellence worldwide.

Qualifications

• Bachelor's degree in engineering or related scientific discipline.
• Minimum 15 years of experience in regulatory affairs, drug development, or technical development in biopharmaceutical/medical device industry.
• Global regulatory strategy expertise for drug-device combinations and CMC frameworks across full product lifecycle.
• Proven track record of health authority interactions, negotiations, and major global drug approvals.
• Experience building relationships with regulators and trade associations to shape external policies.
• Willingness to travel up to 10%.

Responsibilities

• Architect and drive global regulatory strategy for complex technologies across device and pharma domains.
• Champion scalable device platform strategies to accelerate development timelines.
• Partner with Pharma Technical, Pharma Development, Global Pharma Procurement/Supply, and Roche Diagnostics.
• Provide strategic regulatory guidance and high-level decision-making to align with business objectives.
• Represent Roche Pharma in external policy venues and shape regulatory policy.
• Author and disseminate external positions through trade groups and industry venues.
• Build internal device regulatory capabilities and evolve operating models to support device innovation.

Skills

Regulatory strategy

Global regulators

Executive communication

Education

Bachelor's degree in engineering or related scientific field

Job description

Roche seeks a Principal Regulatory Program Director to architect and drive global regulatory strategy for complex drug-device technologies. You will integrate device and pharma regulatory domains, shaping policy while aligning with Roche's strategic objectives.

The role emphasizes leadership, cross-functional collaboration, and stakeholder engagement to accelerate development timelines and ensure regulatory excellence worldwide.