Director, Global Regulatory Lead - Oncology
Takeda
August 12, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
How you will contribute:
- Oversee and execute regulatory activities for one or more complex oncology projects; support assigned projects.
- Serve as Global Regulatory Lead (GRL) on Global Project Teams; may lead Global Regulatory Sub-teams (GRT).
- Act as Primary FDA contact; accountable for US FDA submissions and approvals and for timely, high-quality submission execution (e.g., NDA/BLA/MAA).
- Collaborate with global regions to develop and execute global regulatory strategy for the project(s).
- Communicate regulatory developments impacting success; participate/lead cross-functional taskforces.
- Develop/author and execute global regulatory strategies; monitor regulatory/access trends to strengthen development plans.
- May partner with market access colleagues on regulatory/agency/HTA value evidence interactions.
- May participate in due diligence regulatory assessments for licensing; identify resource gaps and present to senior management.
Minimum Requirements/Qualifications:
- Bachelor’s degree required; scientific discipline strongly preferred; advanced degree strongly preferred.
- 8+ years of pharmaceutical industry experience, including regulatory and/or related experience.
- Strong drug development and regulatory knowledge; FDA knowledge required; EU/Canada/ROW a plus.
- Experience managing major regulatory filings and contributing to regulatory/development strategy.
- Ability to interpret complex scientific issues across projects; strong oral/written communication, timeline management, negotiation, integrity, adaptability.
- Strong, independent regulatory strategy skills; proactive issue identification and risk-mitigation solutions; effective global stakeholder collaboration.
- Oversee and execute regulatory activities for one or more complex oncology projects; support assigned projects.
- Serve as Global Regulatory Lead (GRL) on Global Project Teams; may lead Global Regulatory Sub-teams (GRT).
- Act as Primary FDA contact; accountable for US FDA submissions and approvals and for timely, high-quality submission execution (e.g., NDA/BLA/MAA).
- Collaborate with global regions to develop and execute global regulatory strategy for the project(s).
- Communicate regulatory developments impacting success; participate/lead cross-functional taskforces.
- Develop/author and execute global regulatory strategies; monitor regulatory/access trends to strengthen development plans.
- May partner with market access colleagues on regulatory/agency/HTA value evidence interactions.
- May participate in due diligence regulatory assessments for licensing; identify resource gaps and present to senior management.
Minimum Requirements/Qualifications:
- Bachelor’s degree required; scientific discipline strongly preferred; advanced degree strongly preferred.
- 8+ years of pharmaceutical industry experience, including regulatory and/or related experience.
- Strong drug development and regulatory knowledge; FDA knowledge required; EU/Canada/ROW a plus.
- Experience managing major regulatory filings and contributing to regulatory/development strategy.
- Ability to interpret complex scientific issues across projects; strong oral/written communication, timeline management, negotiation, integrity, adaptability.
- Strong, independent regulatory strategy skills; proactive issue identification and risk-mitigation solutions; effective global stakeholder collaboration.