Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Takeda
June 25, 2026
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Operations
How you will contribute:
- Maintain up-to-date CMC/quality guidelines and regulations (Human Factors); communicate to stakeholders.
- Serve as a global Human Factors key resource and opinion leader (internal/external).
- Influence Human Factors regulations/guidance; advise senior management on implementation strategy.
- Collaborate across Takeda teams to enable regulatory success for drug-device combinations.
- Act as Foundational Subject Matter Expert/Platform Lead for global Human Factors regulation for devices/combination products.
- Provide tactical Human Factors regulatory guidance to product teams.
- Develop Human Factors strategies, tools, and trainings for the combination product regulatory team.
- Author/review/regulatorily assess and input on drug-device combination strategies in filings (clinical through lifecycle).
- Lead regulatory strategy and briefing book authoring and meetings with global health authorities.
- Review/approve device design control documentation (e.g., technology transfer, verification/validation, human factors protocols/reports).
- Identify and escalate combination product/device regulatory risks.
- Support device-related global regulatory submissions (e.g., IND/CTA/IMPD/BLA/MAA/NDA/510(k)/Technical Files/Notified Body opinions).
- Provide input on compliance activities (change controls, deviations, investigations).
- Evaluate new business development opportunities/due diligence participation.
- Develop CMC device & combination product staff on Human Factors.
Minimum Requirements/Qualifications:
- BS/BA in Scientific/Pharmaceutical/Engineering; advanced degree preferred.
- 10+ years device and/or combination product regulatory CMC experience (international plus).
- 10+ years relevant industry experience (pharma + medical devices).
- 2 years management of direct reports desired.
- Human Factors expertise for drug-device combinations.
- Strongly preferred: experience with FDA/EMA/Notified Bodies and device/combination product submissions (including science-based regulatory positions and regulator negotiations).
- Cross-functional leadership, judgment, and excellent written/oral communication.
- Expected: participation in industry forums.
- Ability to provide regulatory advice and reasoned decisions (incl. Design Control issues).
TRAVEL REQUIREMENTS:
- ~10% travel; willingness to travel (including overnight/international).
- Maintain up-to-date CMC/quality guidelines and regulations (Human Factors); communicate to stakeholders.
- Serve as a global Human Factors key resource and opinion leader (internal/external).
- Influence Human Factors regulations/guidance; advise senior management on implementation strategy.
- Collaborate across Takeda teams to enable regulatory success for drug-device combinations.
- Act as Foundational Subject Matter Expert/Platform Lead for global Human Factors regulation for devices/combination products.
- Provide tactical Human Factors regulatory guidance to product teams.
- Develop Human Factors strategies, tools, and trainings for the combination product regulatory team.
- Author/review/regulatorily assess and input on drug-device combination strategies in filings (clinical through lifecycle).
- Lead regulatory strategy and briefing book authoring and meetings with global health authorities.
- Review/approve device design control documentation (e.g., technology transfer, verification/validation, human factors protocols/reports).
- Identify and escalate combination product/device regulatory risks.
- Support device-related global regulatory submissions (e.g., IND/CTA/IMPD/BLA/MAA/NDA/510(k)/Technical Files/Notified Body opinions).
- Provide input on compliance activities (change controls, deviations, investigations).
- Evaluate new business development opportunities/due diligence participation.
- Develop CMC device & combination product staff on Human Factors.
Minimum Requirements/Qualifications:
- BS/BA in Scientific/Pharmaceutical/Engineering; advanced degree preferred.
- 10+ years device and/or combination product regulatory CMC experience (international plus).
- 10+ years relevant industry experience (pharma + medical devices).
- 2 years management of direct reports desired.
- Human Factors expertise for drug-device combinations.
- Strongly preferred: experience with FDA/EMA/Notified Bodies and device/combination product submissions (including science-based regulatory positions and regulator negotiations).
- Cross-functional leadership, judgment, and excellent written/oral communication.
- Expected: participation in industry forums.
- Ability to provide regulatory advice and reasoned decisions (incl. Design Control issues).
TRAVEL REQUIREMENTS:
- ~10% travel; willingness to travel (including overnight/international).