Director, Global Regulatory Lead, GI & Inflammation
Takeda
June 25, 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 and/or multiple projects.
- Provide strategic and tactical advice to teams to ensure timely, efficient development and program maintenance while meeting regulatory requirements.
- Lead within the department and R&D; drive cross-functional initiatives and influence the field.
- Provide leadership and development for direct reports, including global regulatory leads.
Accountabilities:
- Lead Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs in project meetings.
- Ensure global regulatory strategies are implemented, maintained, and adapted to changing regulatory/business needs.
- Keep stakeholders informed of developments impacting regulatory success.
- Anticipate risks; develop and evaluate solutions, including risk-mitigation strategies.
- Accountable for US FDA submissions and approvals for assigned projects (and lead submission types).
- Serve as point of contact for health authorities; lead and manage FDA meetings.
- Partner with regional regulatory leads, functions, and vendors to ensure local affiliate submissions and ongoing product compliance.
- Oversee vendor regulatory activities within project scope.
- Lead or participate in departmental and cross-functional initiatives.
- Lead regulatory due diligence for licensing opportunities.
- Partner with global market access on interactions with regulatory/health authorities/HTA bodies for value evidence.
- Monitor regulatory and access trends to strengthen development plans and adopt timely regulatory strategies.
Education & Competencies:
- Bachelor’s in a scientific discipline (strongly preferred); advanced degree (PharmD/PhD/MD) strongly preferred.
- 8+ years pharmaceutical industry experience, including 6 years regulatory (or combination of 4+ years regulatory/related).
- Preferred: experience reviewing/authoring/managing regulatory submissions.
- Strong drug development and regulatory knowledge (FDA, EU, Canada, ROW; post-marketing a plus).
- Strong oral/written communication; timeline management; negotiation; integrity and adaptability.
- Ability to work effectively in global teams and bring teams together for common objectives.
Benefits (if provided): Hybrid work per policy; U.S. base salary range $177,000–$278,080 plus potential incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 sick hours and up to 120 vacation hours for new hires.
- Define, develop, and lead global regulatory strategies to maximize regulatory success for complex and/or multiple projects.
- Provide strategic and tactical advice to teams to ensure timely, efficient development and program maintenance while meeting regulatory requirements.
- Lead within the department and R&D; drive cross-functional initiatives and influence the field.
- Provide leadership and development for direct reports, including global regulatory leads.
Accountabilities:
- Lead Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs in project meetings.
- Ensure global regulatory strategies are implemented, maintained, and adapted to changing regulatory/business needs.
- Keep stakeholders informed of developments impacting regulatory success.
- Anticipate risks; develop and evaluate solutions, including risk-mitigation strategies.
- Accountable for US FDA submissions and approvals for assigned projects (and lead submission types).
- Serve as point of contact for health authorities; lead and manage FDA meetings.
- Partner with regional regulatory leads, functions, and vendors to ensure local affiliate submissions and ongoing product compliance.
- Oversee vendor regulatory activities within project scope.
- Lead or participate in departmental and cross-functional initiatives.
- Lead regulatory due diligence for licensing opportunities.
- Partner with global market access on interactions with regulatory/health authorities/HTA bodies for value evidence.
- Monitor regulatory and access trends to strengthen development plans and adopt timely regulatory strategies.
Education & Competencies:
- Bachelor’s in a scientific discipline (strongly preferred); advanced degree (PharmD/PhD/MD) strongly preferred.
- 8+ years pharmaceutical industry experience, including 6 years regulatory (or combination of 4+ years regulatory/related).
- Preferred: experience reviewing/authoring/managing regulatory submissions.
- Strong drug development and regulatory knowledge (FDA, EU, Canada, ROW; post-marketing a plus).
- Strong oral/written communication; timeline management; negotiation; integrity and adaptability.
- Ability to work effectively in global teams and bring teams together for common objectives.
Benefits (if provided): Hybrid work per policy; U.S. base salary range $177,000–$278,080 plus potential incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 sick hours and up to 120 vacation hours for new hires.