Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health
Takeda
August 15, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Corporate Functions
Objective / Purpose
- Provides strategic and tactical guidance to deliver global regulatory strategies supporting development and commercialization of biomarkers, diagnostic tests, devices, and digital health tools.
Responsibilities
- 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, strategy alignment, maintenance submissions/notifications) to ensure compliance.
- Integrate drug and diagnostic regulatory plans, including HA engagement and mitigation strategies, into global precision medicine plans.
- Communicate developments impacting regulatory success to stakeholders.
- Anticipate risks and develop solutions with management; understand technical success probabilities.
- Represent Global Regulatory Affairs (GRA) in senior interactions and health authority meetings; engage external partners.
- Lead/participate in cross-functional task forces and initiatives.
- Influence cross-functional colleagues; provide regulatory training.
- Support continuous improvement, innovation, and best practices in regulatory processes.
- Provide regulatory input for diligence/licensing, including governance/management of device/diagnostic partners.
- Monitor trends affecting regulatory and access environments; adopt timely regulatory strategies.
Education & Competencies (Technical/Behavioral)
- Bachelor’s in a scientific discipline (strongly preferred); advanced degree (PhD/MD/PharmD/MS) strongly preferred.
- 5+ years in regulatory affairs (devices/diagnostics in pharma strongly preferred).
- Proven regulatory strategy track record for digital health/diagnostics/precision medicine.
- Expert device development/registration/maintenance knowledge; strong biomarker strategy understanding.
- Experience with FDA/EMA/Notified Bodies and device submissions (e.g., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510(k), CE Mark).
- Knowledge of EU MDR/IVDR; interpret scientific data for regulatory strategy.
- Strong verbal and written communication; translate complex concepts for stakeholders.
Application Instructions
- Apply via the online “Apply” process; provided information is processed per Takeda’s Privacy Notice and Terms of Use.
Compensation & Benefits (if stated)
- US base salary range: $154,400–$242,550. Potential eligibility for incentives and benefits (medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, etc.).
- Provides strategic and tactical guidance to deliver global regulatory strategies supporting development and commercialization of biomarkers, diagnostic tests, devices, and digital health tools.
Responsibilities
- 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, strategy alignment, maintenance submissions/notifications) to ensure compliance.
- Integrate drug and diagnostic regulatory plans, including HA engagement and mitigation strategies, into global precision medicine plans.
- Communicate developments impacting regulatory success to stakeholders.
- Anticipate risks and develop solutions with management; understand technical success probabilities.
- Represent Global Regulatory Affairs (GRA) in senior interactions and health authority meetings; engage external partners.
- Lead/participate in cross-functional task forces and initiatives.
- Influence cross-functional colleagues; provide regulatory training.
- Support continuous improvement, innovation, and best practices in regulatory processes.
- Provide regulatory input for diligence/licensing, including governance/management of device/diagnostic partners.
- Monitor trends affecting regulatory and access environments; adopt timely regulatory strategies.
Education & Competencies (Technical/Behavioral)
- Bachelor’s in a scientific discipline (strongly preferred); advanced degree (PhD/MD/PharmD/MS) strongly preferred.
- 5+ years in regulatory affairs (devices/diagnostics in pharma strongly preferred).
- Proven regulatory strategy track record for digital health/diagnostics/precision medicine.
- Expert device development/registration/maintenance knowledge; strong biomarker strategy understanding.
- Experience with FDA/EMA/Notified Bodies and device submissions (e.g., IND, SRDs, IDEs, CTA, IMPD, BLA, MAA, NDA, 510(k), CE Mark).
- Knowledge of EU MDR/IVDR; interpret scientific data for regulatory strategy.
- Strong verbal and written communication; translate complex concepts for stakeholders.
Application Instructions
- Apply via the online “Apply” process; provided information is processed per Takeda’s Privacy Notice and Terms of Use.
Compensation & Benefits (if stated)
- US base salary range: $154,400–$242,550. Potential eligibility for incentives and benefits (medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, etc.).