Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Takeda
2 days ago
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Corporate Functions
Responsibilities:
- Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across development, registration, commercialization, and lifecycle management.
- Maintain and communicate CMC/quality guidance and regulations (Human Factors) to stakeholders; proactively drive right-first-time filings.
- Act as key opinion leader and foundational subject matter expert for global Human Factors regulation for devices/combination products.
- Influence and advise on implementation strategy as regulations/guidance evolve; provide tactical Human Factors regulatory guidance to product teams.
- Develop Human Factors strategies, tools, and training; author/review inputs for regulatory filings throughout clinical and commercial lifecycle.
- Lead regulatory strategy, briefing books, and meetings with global health authorities.
- Review/approve device design control and Human Factors documentation (e.g., protocols/reports, technology transfer, V&V) for alignment with regulatory requirements and standards.
- Identify and communicate device/combination regulatory risks; support device-related global submissions and compliance activities (change controls, deviations, investigations).
- Collaborate in a matrix environment across GRA to ensure timely execution; evaluate business development opportunities/due diligence teams.
- Develop CMC Device & Combination product staff on Human Factors.
Qualifications:
- BS/BA in scientific/pharmaceutical/engineering discipline; advanced degree preferred.
- 10+ years device/combination product regulatory CMC experience; international experience plus.
- Minimum 10 years relevant industry experience; 2 years direct management desired.
- Proven Human Factors expertise for drug-device combinations.
- Strong experience with FDA/EMA/Notified Bodies and device/combination submissions (e.g., IND/CTA/IMPD/BLA/MAA/NDA/510(k), technical files, post-approval submissions); strong science-based, data-driven regulatory positions and regulator negotiation experience.
- Strong communication, cross-functional collaboration, judgment for elevating issues, and ability to self-direct.
- Active participation in industry forums.
Travel:
- ~10% travel; includes overnight and some international travel.
- Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a focus on Human Factors across development, registration, commercialization, and lifecycle management.
- Maintain and communicate CMC/quality guidance and regulations (Human Factors) to stakeholders; proactively drive right-first-time filings.
- Act as key opinion leader and foundational subject matter expert for global Human Factors regulation for devices/combination products.
- Influence and advise on implementation strategy as regulations/guidance evolve; provide tactical Human Factors regulatory guidance to product teams.
- Develop Human Factors strategies, tools, and training; author/review inputs for regulatory filings throughout clinical and commercial lifecycle.
- Lead regulatory strategy, briefing books, and meetings with global health authorities.
- Review/approve device design control and Human Factors documentation (e.g., protocols/reports, technology transfer, V&V) for alignment with regulatory requirements and standards.
- Identify and communicate device/combination regulatory risks; support device-related global submissions and compliance activities (change controls, deviations, investigations).
- Collaborate in a matrix environment across GRA to ensure timely execution; evaluate business development opportunities/due diligence teams.
- Develop CMC Device & Combination product staff on Human Factors.
Qualifications:
- BS/BA in scientific/pharmaceutical/engineering discipline; advanced degree preferred.
- 10+ years device/combination product regulatory CMC experience; international experience plus.
- Minimum 10 years relevant industry experience; 2 years direct management desired.
- Proven Human Factors expertise for drug-device combinations.
- Strong experience with FDA/EMA/Notified Bodies and device/combination submissions (e.g., IND/CTA/IMPD/BLA/MAA/NDA/510(k), technical files, post-approval submissions); strong science-based, data-driven regulatory positions and regulator negotiation experience.
- Strong communication, cross-functional collaboration, judgment for elevating issues, and ability to self-direct.
- Active participation in industry forums.
Travel:
- ~10% travel; includes overnight and some international travel.