Regulatory Program Director

The Opportunity

The Pharma Technical Regulatory - Devices and Combination Products (PTR-DCP) team is seeking a highly motivated regulatory professional with relevant industry experience to join the team. The successful candidate will be responsible for  developing and executing regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and  guidance. In addition to portfolio-related responsibilities, the individual will play a role to build regulatory capabilities, shape regulatory policy, and establish the necessary device regulatory  infrastructures/processes to support our portfolio. 

What You’ll Do

• At the Regulatory Program Director level, the individual 

  • (a) has in-depth specialist knowledge of own job discipline and broad knowledge  of related disciplines in the field, 

  • (b) contributes by participating in large/global cross-functional teams where they may take a leading role, 

  • (c) may coach colleagues and help others develop  expertise/skills, and (d) navigate in complex situations by applying a diverse skillset.

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

• Lead the development and implementation of global regulatory strategies for devices, including  pioneering innovative regulatory strategies to advance our pipeline and portfolio. Provide  regulatory pathway, requirements, guidance, 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 PTR in device-specific internal initiatives to establish internal regulatory processes  and systems.  

• 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. 

• Stay abreast of changing regulatory requirements. Analyze regulations, rules, or guidance documents  and communicate potential impact to internal stakeholders.

Who You Are

• Must have a scientific degree, an advanced degree desired. 

• 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/Skills/Competencies

• 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 and EU  Medical Device Regulation. 

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

• Excellent communication, collaboration, and interpersonal skills. 

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

• Ability to think “big picture” with focus on details. 

• Ability to think at the system level.  

• Ability to collaborate cross-functionally and divisionally in Roche to leverage regulatory expertise and  achieve business needs in a streamlined manner.  

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

• Drive for continuou