Regulatory Program Director - Devices and Combination Product

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. Join Roche, where every voice matters.

The Position

We focus on the long-term, leading investment in research and development, striving to improve lives today and for generations to come.

The Regulatory Program Director is responsible for developing and driving regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and mentorship. In addition to portfolio-related responsibilities, the individual plays a role to build regulatory capabilities, craft regulatory policy, and establish the vital device regulatory infrastructures/processes to support our portfolio.

At this level, the individual (a) has in-depth specialist knowledge of own job field and broad knowledge of related subject areas in the field, (b) chips in by participating in large/global cross-functional or cross-chapter squads where it may take a leading role, (c) may mentor colleagues and help others develop expertise/skills, and (d) navigates in sophisticated situations by applying a diverse skills.

The Opportunity:

• Serve as the Device Regulatory Lead role on assigned product teams (pre-launch and post-launch):

• Own the development and implementation of global regulatory strategies for devices, including groundbreaking innovative regulatory strategies to advance our pipeline and portfolio. Provide regulatory pathway, requirements, mentorship, and advice to project teams.

• Lead and/or support device related health authorities interactions, in collaboration with internal team members.

• Lead the preparation and submission of relevant device regulatory packages (e.g. briefing packages, pre-submission, IND/CTA, BLA/NDA/MAA, CE-mark, 510(k), de novo, Notified Body Opinion, etc.), including responses to questions from health authorities. Responsible for ensuring high quality and timely compilation of contents for the submissions.

• Identify and manage potential regulatory risks associated with regulatory submissions. Ensure appropriate communication, resolution, and/or escalation (as needed) of regulatory risks.

• Serve as a device regulatory subject matter expert internally and externally to Roche. Provide regular training internally to enhance organizational knowledge and capability. Coach and mentor junior regulatory affairs professionals.

• Lead or represent Pharma Technical Regulatory (PTR) in device-specific internal initiatives to establish internal regulatory processes and systems. Stay abreast of changing regulatory requirements. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders.

• Engage with relevant regulatory bodies and industry groups to influence device regulatory standards and regulations that matter to Roche’s product portfolio.

• Build strong collaborations and relationships with internal stakeholders to ensure successful execution of regulatory submissions.

WHO YOU ARE:

You have a scientific degree, an advanced degree desired with a minimum of 10 years of industry experience in regulatory and/or quality related field in the medical device and/or biopharmaceutical industry, including applicable experience with devices.

• Knowledge of ICH guidance documents and health authority regulations/standards relevant to devices, specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, IEC 62633, ISO 13485, IEC 62304, cybersecurity, mobile medical applications, digital therapeutic, clinical decision support systems, and EU Medical Device Regulation.

• Experience in leading and securing CE-mark, 510(k), PMA, NDA, BLA, IND, CTA regulatory approvals are highly desirable.

• Dynamic personality, ability to think outside the box and take smart risks.

• Ability to think “big picture” and focus on details and to collaborate cross-functionally and divisionally in Roche to leverage regulatory expertise and achieve business needs in a streamline manner.

• Effective problem solving and strong organizational skills, including ability to prioritize tasks.

• Drive for continuous improvements and operate with a lean mindset.

Ability to travel up to 10%. Apply now!

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

Roche is an Equal Opportunity Employer.

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