Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health
Takeda
August 16, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Corporate Functions
Objective/Purpose:
- Provide strategic and tactical guidance to teams to deliver global regulatory strategies supporting development and commercialization of biomarkers, diagnostic tests, devices, and digital health tools.
Accountabilities:
- Develop and lead global regulatory strategies for precision medicine and digital health programs.
- Identify regulatory requirements and provide regulatory guidance to global development teams.
- Partner with local/regional reps to manage lifecycle regulatory activities (change impact assessments, regulatory alignment, maintenance submissions/notifications) to ensure compliance across markets.
- Integrate drug and diagnostic regulatory/submission plans (including HA engagement and mitigation strategies) into global regulatory plans.
- Advise line management/stakeholders on regulatory developments impacting success; anticipate risks and develop solutions.
- Represent Global Regulatory Affairs (GRA) in governance technical reviews, global health authority meetings, and with external partners.
- Participate/lead cross-functional initiatives; influence enterprise and therapeutic-area teams.
- Train cross-functional teams on regulatory requirements and processes; drive continuous improvement and adoption of best practices.
- Support diligence for licensing opportunities, including regulatory input on device/diagnostic partner selection and management.
- Monitor trends affecting regulatory and access environments; support regulatory/policy engagement (draft/review guidance comments; trade association working groups).
Qualifications/Skills:
- Bachelor’s in a scientific discipline (strongly preferred); advanced scientific degree (PhD/MD/PharmD/MS) strongly preferred.
- 5+ years regulatory affairs experience; medical device/diagnostics experience in pharma strongly preferred.
- Proven track record managing regulatory strategies for digital health/diagnostics/precision medicine.
- Expert knowledge of device registration/maintenance; strong biomarker strategy understanding.
- Demonstrated FDA/EMA/Notified Body and global authority experience with device submission types (e.g., IND, IDE, CTA, IMPD, BLA, MAA, NDA, 510(k), CE Mark) and amendments.
- Knowledge of EU MDR/IVDR; ability to interpret scientific data and communicate complex concepts clearly.
Location/Type:
- Remote within the US (Massachusetts - Virtual); Full-time, Regular.
Compensation/Benefits (as stated):
- Base salary range: $154,400–$242,550.
- Possible incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, paid 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 and submit information for processing under Takeda’s Privacy Notice and Terms of Use.
- Provide strategic and tactical guidance to teams to deliver global regulatory strategies supporting development and commercialization of biomarkers, diagnostic tests, devices, and digital health tools.
Accountabilities:
- Develop and lead global regulatory strategies for precision medicine and digital health programs.
- Identify regulatory requirements and provide regulatory guidance to global development teams.
- Partner with local/regional reps to manage lifecycle regulatory activities (change impact assessments, regulatory alignment, maintenance submissions/notifications) to ensure compliance across markets.
- Integrate drug and diagnostic regulatory/submission plans (including HA engagement and mitigation strategies) into global regulatory plans.
- Advise line management/stakeholders on regulatory developments impacting success; anticipate risks and develop solutions.
- Represent Global Regulatory Affairs (GRA) in governance technical reviews, global health authority meetings, and with external partners.
- Participate/lead cross-functional initiatives; influence enterprise and therapeutic-area teams.
- Train cross-functional teams on regulatory requirements and processes; drive continuous improvement and adoption of best practices.
- Support diligence for licensing opportunities, including regulatory input on device/diagnostic partner selection and management.
- Monitor trends affecting regulatory and access environments; support regulatory/policy engagement (draft/review guidance comments; trade association working groups).
Qualifications/Skills:
- Bachelor’s in a scientific discipline (strongly preferred); advanced scientific degree (PhD/MD/PharmD/MS) strongly preferred.
- 5+ years regulatory affairs experience; medical device/diagnostics experience in pharma strongly preferred.
- Proven track record managing regulatory strategies for digital health/diagnostics/precision medicine.
- Expert knowledge of device registration/maintenance; strong biomarker strategy understanding.
- Demonstrated FDA/EMA/Notified Body and global authority experience with device submission types (e.g., IND, IDE, CTA, IMPD, BLA, MAA, NDA, 510(k), CE Mark) and amendments.
- Knowledge of EU MDR/IVDR; ability to interpret scientific data and communicate complex concepts clearly.
Location/Type:
- Remote within the US (Massachusetts - Virtual); Full-time, Regular.
Compensation/Benefits (as stated):
- Base salary range: $154,400–$242,550.
- Possible incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, paid 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 and submit information for processing under Takeda’s Privacy Notice and Terms of Use.