Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Takeda
August 08, 2026
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Corporate Functions
Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations (Human Factors)
How you will contribute:
- Maintain and communicate up-to-date CMC/quality guidelines and Human Factors regulations.
- Influence globally as a key opinion leader/resource on Human Factors for drug-device combinations.
- Advise senior management on Human Factors regulatory strategy; plan, evaluate, and recommend implementation.
- Collaborate across Takeda to enable CMC regulatory team success for drug-device combination filings.
- Serve as Foundational Subject Matter Expert/Platform Lead for global Human Factors device/combination regulation.
- Provide tactical Human Factors regulatory guidance to product teams.
- Develop Human Factors strategies, tools, and trainings for the combination product regulatory team.
- Author/review filings and provide assessments/input across clinical development and commercial lifecycle.
- Lead regulatory strategy, briefing book authoring, and meetings with global health authorities.
- Review/approve design control and Human Factors documentation (e.g., protocols, reports) for regulatory alignment.
- Identify regulatory risks and ensure timely escalation.
- Support/lead device-related components of submissions (e.g., IND, CTA, BLA, MAA, Variations, Technical Files, Notified Body opinions).
- Provide input on product compliance activities (change controls, deviations, investigations).
- Evaluate BD opportunities/due diligence.
- Develop CMC Device & Combination product staff on Human Factors.
Minimum Requirements/Qualifications:
- BS/BA in Scientific/Pharmaceutical/Engineering discipline; Advanced degree preferred.
- 10+ years in device and/or combination product role in pharma/medical devices with regulatory CMC experience; international experience a plus.
- 2 years management of direct reports desired.
- Human Factors expertise for drug-device combinations.
- Strong preference: experience with FDA/EMA/Notified Bodies/global health authorities on combination product/device submissions and conducting negotiations with regulators.
- Experience leading cross-functional teams; excellent written/oral communication.
- Ability to self-direct and provide reasoned regulatory advice (especially Design Control).
Travel requirements: ~10% travel (including some international).
Benefits/compensation (if applicable in role posting): medical/dental/vision, 401(k) match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours sick time and up to 120 hours paid vacation for new hires.
Application instructions:
- Apply via the “Apply” button.
How you will contribute:
- Maintain and communicate up-to-date CMC/quality guidelines and Human Factors regulations.
- Influence globally as a key opinion leader/resource on Human Factors for drug-device combinations.
- Advise senior management on Human Factors regulatory strategy; plan, evaluate, and recommend implementation.
- Collaborate across Takeda to enable CMC regulatory team success for drug-device combination filings.
- Serve as Foundational Subject Matter Expert/Platform Lead for global Human Factors device/combination regulation.
- Provide tactical Human Factors regulatory guidance to product teams.
- Develop Human Factors strategies, tools, and trainings for the combination product regulatory team.
- Author/review filings and provide assessments/input across clinical development and commercial lifecycle.
- Lead regulatory strategy, briefing book authoring, and meetings with global health authorities.
- Review/approve design control and Human Factors documentation (e.g., protocols, reports) for regulatory alignment.
- Identify regulatory risks and ensure timely escalation.
- Support/lead device-related components of submissions (e.g., IND, CTA, BLA, MAA, Variations, Technical Files, Notified Body opinions).
- Provide input on product compliance activities (change controls, deviations, investigations).
- Evaluate BD opportunities/due diligence.
- Develop CMC Device & Combination product staff on Human Factors.
Minimum Requirements/Qualifications:
- BS/BA in Scientific/Pharmaceutical/Engineering discipline; Advanced degree preferred.
- 10+ years in device and/or combination product role in pharma/medical devices with regulatory CMC experience; international experience a plus.
- 2 years management of direct reports desired.
- Human Factors expertise for drug-device combinations.
- Strong preference: experience with FDA/EMA/Notified Bodies/global health authorities on combination product/device submissions and conducting negotiations with regulators.
- Experience leading cross-functional teams; excellent written/oral communication.
- Ability to self-direct and provide reasoned regulatory advice (especially Design Control).
Travel requirements: ~10% travel (including some international).
Benefits/compensation (if applicable in role posting): medical/dental/vision, 401(k) match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, up to 80 hours sick time and up to 120 hours paid vacation for new hires.
Application instructions:
- Apply via the “Apply” button.