Director, Global Regulatory Lead - Oncology
Takeda
June 30, 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 multiple complex projects; support regulatory activities for assigned projects.
- Serve as Global Regulatory Lead (GRL) on the global project team (GPT) for responsible project(s).
- May lead the Global Regulatory Sub-team (GRT) and/or serve as global/regional regulatory lead as a GRT member.
- Primary FDA contact; accountable for all US FDA submissions and approvals for responsible project(s).
- Ensure submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA).
- Collaborate across Takeda regions to create and execute global regulatory strategy.
- Communicate regulatory developments impacting success to stakeholders timely and professionally.
- Participate with influence in or lead departmental/cross-functional task forces.
- May partner with market access on interactions with regulatory/health agencies/HTA bodies on value evidence.
- Develop/author and execute global regulatory strategies; monitor trends impacting regulatory and access environments.
- May lead regulatory assessment in due diligence teams for licensing opportunities.
- Identify/propose solutions for resource gaps; may present to senior management.
Minimum Requirements/Qualifications:
- Bachelor’s required (scientific discipline strongly preferred); advanced degree strongly preferred.
- 8+ years pharmaceutical industry experience including regulatory and/or related experience.
- Solid knowledge of drug development and regulatory requirements; FDA knowledge required (EU/Canada/ROW a plus).
- Experience managing major regulatory filings; significant contributor to regulatory/development strategies.
- Strong communications, negotiation, integrity, adaptability; regulatory strategy independence.
- Strong global teamwork and ability to communicate with senior leadership.
Benefits (explicitly stated): Hybrid classification; for U.S. employees may be eligible for incentives and insurance (medical/dental/vision), 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time, and up to 120 hours paid vacation at new hire accrual.
- Oversee and execute regulatory activities for one or multiple complex projects; support regulatory activities for assigned projects.
- Serve as Global Regulatory Lead (GRL) on the global project team (GPT) for responsible project(s).
- May lead the Global Regulatory Sub-team (GRT) and/or serve as global/regional regulatory lead as a GRT member.
- Primary FDA contact; accountable for all US FDA submissions and approvals for responsible project(s).
- Ensure submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA).
- Collaborate across Takeda regions to create and execute global regulatory strategy.
- Communicate regulatory developments impacting success to stakeholders timely and professionally.
- Participate with influence in or lead departmental/cross-functional task forces.
- May partner with market access on interactions with regulatory/health agencies/HTA bodies on value evidence.
- Develop/author and execute global regulatory strategies; monitor trends impacting regulatory and access environments.
- May lead regulatory assessment in due diligence teams for licensing opportunities.
- Identify/propose solutions for resource gaps; may present to senior management.
Minimum Requirements/Qualifications:
- Bachelor’s required (scientific discipline strongly preferred); advanced degree strongly preferred.
- 8+ years pharmaceutical industry experience including regulatory and/or related experience.
- Solid knowledge of drug development and regulatory requirements; FDA knowledge required (EU/Canada/ROW a plus).
- Experience managing major regulatory filings; significant contributor to regulatory/development strategies.
- Strong communications, negotiation, integrity, adaptability; regulatory strategy independence.
- Strong global teamwork and ability to communicate with senior leadership.
Benefits (explicitly stated): Hybrid classification; for U.S. employees may be eligible for incentives and insurance (medical/dental/vision), 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time, and up to 120 hours paid vacation at new hire accrual.