Associate Director, Global Regulatory Lead, Oncology
Takeda
August 14, 2026
Remote friendly (Boston, MA)
United States
$154,400 - $242,550 USD yearly
Corporate Functions
Associate Director, Global Regulatory Lead Oncology
How you will contribute
- Define, develop, and lead global regulatory strategies to maximize regulatory success for complex and/or multiple oncology projects.
- May lead Global Regulatory Teams (GRTs) and serve as global and/or regional regulatory lead.
- Act as primary FDA contact; accountable for US FDA submissions and approvals for assigned projects.
- Lead/manage FDA meetings and serve as a point of contact with health authorities.
- Provide tactical guidance and ensure global regulatory strategy is updated and executed with global compliance (may oversee direct reports/junior staff).
- Collaborate across Takeda regions to ensure global strategy execution for projects.
- Communicate developments affecting regulatory success to stakeholders.
- Participate in or lead departmental and cross-functional initiatives/task-forces.
- May partner with global market access on regulatory/health authority/HTA value evidence topics.
- May lead regulatory assessments for due diligence licensing opportunities.
- Monitor/anticipate regulatory and access trends to strengthen development plans and regulatory strategy.
Minimum Requirements/Qualifications
- Bachelor’s degree required (scientific discipline strongly preferred); advanced scientific degree strongly preferred.
- 6+ years pharmaceutical industry experience, including regulatory and/or related experience.
- Solid drug development and regulatory knowledge (FDA, EU, Canada, ROW; post-marketing a plus).
- Preferred: experience reviewing/authoring/managing regulatory submission components.
- Strong oral/written communication, timeline management, negotiation, integrity, and adaptability.
- Ability to interpret complex scientific issues and proactively identify regulatory issues with risk-mitigation strategies.
Benefits (if applicable—explicitly stated)
- Eligible for medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid vacation/sick time, and other well-being benefits (U.S. based employees).
Location/Work Type
- Boston, MA; hybrid.
Application instructions
- Apply via the “Apply” button.
How you will contribute
- Define, develop, and lead global regulatory strategies to maximize regulatory success for complex and/or multiple oncology projects.
- May lead Global Regulatory Teams (GRTs) and serve as global and/or regional regulatory lead.
- Act as primary FDA contact; accountable for US FDA submissions and approvals for assigned projects.
- Lead/manage FDA meetings and serve as a point of contact with health authorities.
- Provide tactical guidance and ensure global regulatory strategy is updated and executed with global compliance (may oversee direct reports/junior staff).
- Collaborate across Takeda regions to ensure global strategy execution for projects.
- Communicate developments affecting regulatory success to stakeholders.
- Participate in or lead departmental and cross-functional initiatives/task-forces.
- May partner with global market access on regulatory/health authority/HTA value evidence topics.
- May lead regulatory assessments for due diligence licensing opportunities.
- Monitor/anticipate regulatory and access trends to strengthen development plans and regulatory strategy.
Minimum Requirements/Qualifications
- Bachelor’s degree required (scientific discipline strongly preferred); advanced scientific degree strongly preferred.
- 6+ years pharmaceutical industry experience, including regulatory and/or related experience.
- Solid drug development and regulatory knowledge (FDA, EU, Canada, ROW; post-marketing a plus).
- Preferred: experience reviewing/authoring/managing regulatory submission components.
- Strong oral/written communication, timeline management, negotiation, integrity, and adaptability.
- Ability to interpret complex scientific issues and proactively identify regulatory issues with risk-mitigation strategies.
Benefits (if applicable—explicitly stated)
- Eligible for medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid vacation/sick time, and other well-being benefits (U.S. based employees).
Location/Work Type
- Boston, MA; hybrid.
Application instructions
- Apply via the “Apply” button.