Genentech · 5 hours ago
Regulatory Program Director
San Francisco, CA
Full-time
Onsite
Director/Executive
$156K/yr - $289K/yr
10+ years expGenentech is seeking a highly motivated Regulatory Program Director to join their Pharma Technical Regulatory - Devices and Combination Products team. The successful candidate will be responsible for developing and executing regulatory strategies for combination products and standalone physical devices, while also building regulatory capabilities and establishing necessary infrastructures to support the portfolio.
BiotechnologyLife ScienceManufacturing
Responsibilities
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
Qualification
Required
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
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 continuous improvements and operate with a lean mindset
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
Recent News
2026-01-23
Genetic Engineering News
2026-01-23
Company data provided by crunchbase