Associate Director, Global Regulatory Lead, Oncology
Takeda
July 02, 2026
Remote friendly (Boston, MA)
United States
$154,400 - $242,550 USD yearly
Corporate Functions
How you will contribute
- Define, develop, and lead global regulatory strategies to maximize success toward program objectives for complex/multiple projects.
- May lead Global Regulatory Teams (GRTs) for assigned projects.
- May serve as global and/or regional regulatory lead within a GRT.
- Serve as primary FDA contact for projects of responsibility; accountable for all US FDA submissions and approvals.
- Act as point of contact with health authorities; lead/manage FDA meetings.
- Provide tactical guidance and collaborate cross-functionally to update/execute global regulatory strategy and ensure regulatory compliance (may oversee direct reports/junior staff).
- Collaborate with all Takeda regions to create and execute global regulatory strategy for projects in area of responsibility.
- Communicate developments that may impact regulatory success to team/stakeholders.
- Participate with influence in or lead departmental and cross-functional task forces/initiatives.
- May partner with global market access on interactions with regulatory/health agency/HTA bodies on product value evidence topics.
- May lead regulatory assessment in due diligence teams for licensing opportunities.
- Monitor/anticipate regulatory and access trends to strengthen development plans and adopt strategies timely.
Minimum Requirements/Qualifications
- Bachelor’s degree required (scientific discipline strongly preferred); advanced degree strongly preferred.
- 6+ years pharmaceutical industry experience including regulatory and/or related experience.
- Solid knowledge of drug development process and regulatory requirements (FDA, EU, Canada, ROW; post-marketing a plus).
- Preferred: experience reviewing/authoring/managing regulatory submission components.
- Strong oral/written communication, timeline management, negotiation, integrity, adaptability.
- Ability to interpret complex scientific issues across multiple projects and proactively identify regulatory issues.
- Must work well with others in global teams; bring teams together for common objectives.
- Define, develop, and lead global regulatory strategies to maximize success toward program objectives for complex/multiple projects.
- May lead Global Regulatory Teams (GRTs) for assigned projects.
- May serve as global and/or regional regulatory lead within a GRT.
- Serve as primary FDA contact for projects of responsibility; accountable for all US FDA submissions and approvals.
- Act as point of contact with health authorities; lead/manage FDA meetings.
- Provide tactical guidance and collaborate cross-functionally to update/execute global regulatory strategy and ensure regulatory compliance (may oversee direct reports/junior staff).
- Collaborate with all Takeda regions to create and execute global regulatory strategy for projects in area of responsibility.
- Communicate developments that may impact regulatory success to team/stakeholders.
- Participate with influence in or lead departmental and cross-functional task forces/initiatives.
- May partner with global market access on interactions with regulatory/health agency/HTA bodies on product value evidence topics.
- May lead regulatory assessment in due diligence teams for licensing opportunities.
- Monitor/anticipate regulatory and access trends to strengthen development plans and adopt strategies timely.
Minimum Requirements/Qualifications
- Bachelor’s degree required (scientific discipline strongly preferred); advanced degree strongly preferred.
- 6+ years pharmaceutical industry experience including regulatory and/or related experience.
- Solid knowledge of drug development process and regulatory requirements (FDA, EU, Canada, ROW; post-marketing a plus).
- Preferred: experience reviewing/authoring/managing regulatory submission components.
- Strong oral/written communication, timeline management, negotiation, integrity, adaptability.
- Ability to interpret complex scientific issues across multiple projects and proactively identify regulatory issues.
- Must work well with others in global teams; bring teams together for common objectives.