Director, Global Regulatory Lead, GI & Inflammation
Takeda
August 29, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Corporate Functions
Objective / Purpose:
- Define, develop, and lead global regulatory strategies to maximize regulatory success for complex/multiple projects.
- Provide strategic and tactical guidance to ensure timely program development and maintenance while ensuring regulatory compliance.
- Lead across R&D and cross-functional initiatives; influence the field as applicable.
- Lead and develop direct reports (including global regulatory leads) responsible for designing and executing global regulatory strategies.
Accountabilities:
- Lead Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs in project meetings.
- Ensure global regulatory strategies are implemented and maintained in line with regulatory and business changes.
- Communicate developments impacting regulatory success to stakeholders; use sound judgment.
- Anticipate risks, develop solutions, and assess probabilities of technical success.
- Accountable for US FDA submissions and approvals for assigned project(s); lead all submission types.
- Serve as direct point of contact with health authorities; lead/manage FDA meetings.
- Partner with regional regulatory leads, other functions, and vendors to provide compliant submissions to local Takeda affiliates.
- Oversee vendor regulatory activities/submissions; participate in/lead cross-functional task forces and licensing diligence.
Education & Competencies / Qualifications:
- Bachelor’s degree (scientific discipline strongly preferred).
- Advanced degree (PharmD/PhD/MD strongly preferred).
- 8+ years pharma industry experience, including 6+ years regulatory (or 4+ years regulatory/related).
- Preferred experience authoring/reviewing/managing regulatory submission components.
- Strong knowledge of drug development and regulatory requirements (FDA/EU/Canada/ROW; post-marketing a plus).
- Strong scientific/data interpretation, communication, negotiation, and timeline management; proven independence in regulatory strategy.
Benefits (explicitly stated):
- Up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location/Work model:
- Boston, MA; hybrid.
- Define, develop, and lead global regulatory strategies to maximize regulatory success for complex/multiple projects.
- Provide strategic and tactical guidance to ensure timely program development and maintenance while ensuring regulatory compliance.
- Lead across R&D and cross-functional initiatives; influence the field as applicable.
- Lead and develop direct reports (including global regulatory leads) responsible for designing and executing global regulatory strategies.
Accountabilities:
- Lead Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs in project meetings.
- Ensure global regulatory strategies are implemented and maintained in line with regulatory and business changes.
- Communicate developments impacting regulatory success to stakeholders; use sound judgment.
- Anticipate risks, develop solutions, and assess probabilities of technical success.
- Accountable for US FDA submissions and approvals for assigned project(s); lead all submission types.
- Serve as direct point of contact with health authorities; lead/manage FDA meetings.
- Partner with regional regulatory leads, other functions, and vendors to provide compliant submissions to local Takeda affiliates.
- Oversee vendor regulatory activities/submissions; participate in/lead cross-functional task forces and licensing diligence.
Education & Competencies / Qualifications:
- Bachelor’s degree (scientific discipline strongly preferred).
- Advanced degree (PharmD/PhD/MD strongly preferred).
- 8+ years pharma industry experience, including 6+ years regulatory (or 4+ years regulatory/related).
- Preferred experience authoring/reviewing/managing regulatory submission components.
- Strong knowledge of drug development and regulatory requirements (FDA/EU/Canada/ROW; post-marketing a plus).
- Strong scientific/data interpretation, communication, negotiation, and timeline management; proven independence in regulatory strategy.
Benefits (explicitly stated):
- Up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
Location/Work model:
- Boston, MA; hybrid.