Senior Director, Global Regulatory Lead – Oncology
Takeda
July 01, 2026
Remote friendly (Boston, MA)
United States
$212,000 - $333,190 USD yearly
Corporate Functions
Application process:
By clicking “Apply,” I understand my employment application process will commence and my information will be processed per Takeda’s Privacy Notice and Terms of Use.
Responsibilities:
- Lead global regulatory strategy for assigned oncology programs across development stages; provide strategic/operational/tactical regulatory insight.
- Interface with Global Project Team to support cross-functional objectives; serve as Global Regulatory Lead for priority programs.
- Lead Global Regulatory Teams developing innovative global regulatory strategies aligned with applicable regulations and business objectives.
- Ensure alignment with leadership; present regulatory assessments and recommendations.
- Keep stakeholders informed of developments impacting regulatory success.
- Accountable for US FDA submissions/approvals; may serve as primary FDA point of contact.
- Ensure timely, high-quality submission execution (e.g., NDA/BLA/MAA).
- Collaborate with regions to create and execute global regulatory strategy.
- Partner with market access on regulatory/agency/HTA value-evidence interactions.
- Develop/author and execute global regulatory strategies; monitor trends affecting regulatory and access environments.
- May lead regulatory assessment for licensing due diligence; identify solutions for resource gaps.
Minimum Requirements/Qualifications:
- BSc/BA (scientific discipline strongly preferred); PharmD/PhD/MD strongly preferred.
- 12+ years pharma industry experience (incl. 10 years regulatory, or 8+ years regulatory/related).
- Experience authoring/reviewing/managing late-stage regulatory submission components.
- Solid drug development + regulatory knowledge (FDA/EU/Canada/ROW; post-marketing a plus).
- Strong scientific/regulatory data interpretation; excellent written/oral communication, negotiation, integrity, adaptability; works well in global teams.
Benefits (U.S. based employees, if eligible):
Medical/dental/vision, 401(k) + match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time (up to 80 hours/year), and paid vacation (up to 120 hours for new hires).
By clicking “Apply,” I understand my employment application process will commence and my information will be processed per Takeda’s Privacy Notice and Terms of Use.
Responsibilities:
- Lead global regulatory strategy for assigned oncology programs across development stages; provide strategic/operational/tactical regulatory insight.
- Interface with Global Project Team to support cross-functional objectives; serve as Global Regulatory Lead for priority programs.
- Lead Global Regulatory Teams developing innovative global regulatory strategies aligned with applicable regulations and business objectives.
- Ensure alignment with leadership; present regulatory assessments and recommendations.
- Keep stakeholders informed of developments impacting regulatory success.
- Accountable for US FDA submissions/approvals; may serve as primary FDA point of contact.
- Ensure timely, high-quality submission execution (e.g., NDA/BLA/MAA).
- Collaborate with regions to create and execute global regulatory strategy.
- Partner with market access on regulatory/agency/HTA value-evidence interactions.
- Develop/author and execute global regulatory strategies; monitor trends affecting regulatory and access environments.
- May lead regulatory assessment for licensing due diligence; identify solutions for resource gaps.
Minimum Requirements/Qualifications:
- BSc/BA (scientific discipline strongly preferred); PharmD/PhD/MD strongly preferred.
- 12+ years pharma industry experience (incl. 10 years regulatory, or 8+ years regulatory/related).
- Experience authoring/reviewing/managing late-stage regulatory submission components.
- Solid drug development + regulatory knowledge (FDA/EU/Canada/ROW; post-marketing a plus).
- Strong scientific/regulatory data interpretation; excellent written/oral communication, negotiation, integrity, adaptability; works well in global teams.
Benefits (U.S. based employees, if eligible):
Medical/dental/vision, 401(k) + match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time (up to 80 hours/year), and paid vacation (up to 120 hours for new hires).