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.

• 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.
• Execute lab experiments according to predefined experimental design and protocols.
• Support the maintenance of essential equipment and critical raw materials to ensure smooth laboratory operations.
• Maintain comprehensive and accurate documentation with a high level of detail. Close out experiments in a timely manner while preparing and submitting well-written development reports.
• Collaborate with team members to ensure the DSP laboratories are maintained in a professional and organized working environment.
• Contribute to the troubleshooting, optimization, and scale-up of downstream processes to meet project objectives.

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 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 and to think at the system level.
• Ability to collaborate cross-functionally and divisionally to leverage regulatory expertise and achieve business needs in a streamlined manner.
• Effective problem solving and strong organizational skills, including…