Director, Global Regulatory Lead, GI & Inflammation

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 ensure timely, efficient program development and maintenance while ensuring compliance with regulatory requirements.
- Lead cross-functionally within R&D, influencing applicable initiatives.
- Lead and develop direct reports, including global regulatory leads designing and executing global regulatory strategies.

Accountabilities:
- Lead Global Regulatory Teams (GRTs) and sub-working groups; define strategy, provide tactical guidance, and ensure global regulatory compliance.
- Implement and maintain global regulatory strategies aligned with changing regulatory and business needs.
- Communicate developments impacting regulatory success to stakeholders.
- Anticipate risks, develop solutions, and assess probabilities of technical success.
- Accountable for all US FDA submissions and approvals for assigned projects; lead all submission types.
- Serve as point of contact for health authorities; lead/manage FDA meetings.
- Ensure global regulatory submissions comply with local regulations for Takeda affiliates; oversee vendor regulatory activities.
- Lead due diligence for licensing opportunities; partner with market access on value evidence interactions.

Education & Competencies (Qualifications):
- Bachelor’s degree (scientific discipline strongly preferred).
- Advanced degree (PharmD/PhD/MD strongly preferred).
- 8+ years in pharmaceutical industry (including 6+ years regulatory, or 4+ years regulatory/related).
- Preferred experience authoring/reviewing/managing regulatory submissions.
- Strong knowledge of drug development and regulatory requirements (FDA, EU, Canada, ROW; post-marketing a plus).
- Strong oral/written communication, negotiation, integrity, adaptability; ability to work in global teams.

Application instruction:
- Apply via the “Apply” button.