Director, Global Regulatory Lead, GI & Inflammation

Objective / Purpose:
- Define, develop, and lead global strategies to maximize global regulatory success for complex and/or multiple projects.
- Provide strategic and tactical advice to teams to ensure timely, efficient development/maintenance while meeting applicable regulatory requirements.
- Lead cross-functionally within the department and R&D, influencing field activities as applicable.
- Provide leadership and development for direct reports, including global regulatory leads responsible for designing and executing global regulatory strategies with regional counterparts.

Accountabilities:
- Lead complex/highly complex/multiple projects; lead Global Regulatory Teams (GRTs) and sub-working groups (e.g., Label Working Group); represent GRTs in project meetings.
- Define strategies and provide tactical guidance; update and execute global regulatory strategy to ensure regulatory compliance.
- Implement and maintain global regulatory strategies aligned to changing regulatory/business needs; anticipate and adapt strategies.
- Communicate developments affecting regulatory success to project teams, management, and stakeholders.
- Anticipate risks, develop solutions, and discuss with team/management (including assessing probabilities of technical success).
- Accountable for US FDA submissions and approvals for assigned project(s) (or oversee direct reports); lead all submission types.
- Serve as direct point of contact with health authorities; lead/manage FDA meetings.
- Collaborate with regulatory regional leads, functions, and vendors to provide compliant submissions to local Takeda affiliates.
- Oversee vendor regulatory responsibilities for in-scope projects.
- Participate in and/or lead departmental and cross-functional task forces and initiatives.
- Lead regulatory review in due diligence for licensing opportunities.
- Partner with global market access on joint regulatory/health agency/HTA value evidence topics (as applicable).
- Monitor and anticipate regulatory/access trends to strengthen product development plans and adopt timely regulatory strategies.

Education & Competencies:
- Bachelor’s degree in a scientific discipline (strongly preferred).
- Advanced degree (PharmD/PhD/MD) (strongly preferred).
- 8+ years pharmaceutical industry experience, including 6 years regulatory experience or 4+ years regulatory/related experience.
- Preferred experience reviewing, authoring, or managing regulatory submission components.
- Solid drug development process and regulatory requirements knowledge; FDA, EU, Canada, ROW; post-marketing a plus.
- Ability to interpret complex scientific issues and data and translate them into regulatory requirements/strategy.
- Strong oral/written communication, timeline management, negotiation, integrity, and adaptability.
- Demonstrated increasing independence in regulatory strategy; identifies regulatory issues and proposes creative, risk-mitigating solutions.
- Ability to work effectively in global teams and bring teams together to achieve shared objectives.