Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Takeda
August 29, 2026
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Corporate Functions
How you will contribute:
- Maintain up-to-date knowledge of relevant CMC/quality guidelines and Human Factors regulations; communicate to stakeholders.
- Serve as a key opinion leader/resource globally on Human Factors (Takeda and external stakeholders).
- Advise senior management on Human Factors implementation strategy; influence changing regulations/guidance.
- Collaborate across Takeda teams to enable CMC regulatory success for drug-device combinations and allied filings.
- Act as Foundational Subject Matter Expert/Platform Lead for global Human Factors regulation for devices and combination products.
- Provide tactical Human Factors regulatory guidance to product teams aligned to global regulatory strategies.
- Develop strategies, tools, and trainings for the regulatory team on Human Factors.
- Author/review/assess and provide input on drug-device combination regulatory strategies across clinical development and commercial lifecycle.
- Lead regulatory strategy, briefing book authoring, and meetings with global health authorities.
- Review/approve device development design control documentation (e.g., technology transfer protocols; design verification/validation; technical reports; Human Factors protocols/reports) for regulatory alignment.
- Identify and communicate regulatory risks; support/lead device-related global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions).
- Provide global input for product-compliance activities (change controls, deviations, investigations).
- Evaluate new business development opportunities/due diligence participation.
- Develop/maintain stakeholder relationships; 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 experience in pharma/medical devices with regulatory CMC (international experience a plus).
- Minimum 10 years relevant industry experience (pharma + medical devices combinations).
- 2 years management of direct reports desired.
- Cross-functional experience (technical quality and commercial manufacturing/supply), leading/influencing regulatory positions.
- Proven Human Factors expertise for drug-device combinations.
- Strongly preferred experience with FDA/EMA/Notified Bodies and global authorities for combination product/device submissions (e.g., IND/CTA/IMPD/BLA/MAA/NDA/510(k)/Notified Body Opinions/Technical Files/post-approval), including negotiating science-based data-driven positions.
- Emerging leadership, problem-solving, flexibility, teamwork; good judgment in escalating issues.
- Excellent written/oral communication with cross-organization engagement.
- Ability to self-direct and manage/regulate tasks; collaborate across GRA liaisons/leads.
- Active participation in industry forums.
- Ability to provide regulatory advice and reasoned decisions with emphasis on Design Control issues.
TRAVEL REQUIREMENTS:
- ~10% travel; willingness to travel including overnight trips (some international travel may be required).
- Maintain up-to-date knowledge of relevant CMC/quality guidelines and Human Factors regulations; communicate to stakeholders.
- Serve as a key opinion leader/resource globally on Human Factors (Takeda and external stakeholders).
- Advise senior management on Human Factors implementation strategy; influence changing regulations/guidance.
- Collaborate across Takeda teams to enable CMC regulatory success for drug-device combinations and allied filings.
- Act as Foundational Subject Matter Expert/Platform Lead for global Human Factors regulation for devices and combination products.
- Provide tactical Human Factors regulatory guidance to product teams aligned to global regulatory strategies.
- Develop strategies, tools, and trainings for the regulatory team on Human Factors.
- Author/review/assess and provide input on drug-device combination regulatory strategies across clinical development and commercial lifecycle.
- Lead regulatory strategy, briefing book authoring, and meetings with global health authorities.
- Review/approve device development design control documentation (e.g., technology transfer protocols; design verification/validation; technical reports; Human Factors protocols/reports) for regulatory alignment.
- Identify and communicate regulatory risks; support/lead device-related global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions).
- Provide global input for product-compliance activities (change controls, deviations, investigations).
- Evaluate new business development opportunities/due diligence participation.
- Develop/maintain stakeholder relationships; 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 experience in pharma/medical devices with regulatory CMC (international experience a plus).
- Minimum 10 years relevant industry experience (pharma + medical devices combinations).
- 2 years management of direct reports desired.
- Cross-functional experience (technical quality and commercial manufacturing/supply), leading/influencing regulatory positions.
- Proven Human Factors expertise for drug-device combinations.
- Strongly preferred experience with FDA/EMA/Notified Bodies and global authorities for combination product/device submissions (e.g., IND/CTA/IMPD/BLA/MAA/NDA/510(k)/Notified Body Opinions/Technical Files/post-approval), including negotiating science-based data-driven positions.
- Emerging leadership, problem-solving, flexibility, teamwork; good judgment in escalating issues.
- Excellent written/oral communication with cross-organization engagement.
- Ability to self-direct and manage/regulate tasks; collaborate across GRA liaisons/leads.
- Active participation in industry forums.
- Ability to provide regulatory advice and reasoned decisions with emphasis on Design Control issues.
TRAVEL REQUIREMENTS:
- ~10% travel; willingness to travel including overnight trips (some international travel may be required).