Associate Director, Global Regulatory Affairs - GI & Inflammation

Role Summary

Associate Director, Global Regulatory Affairs - GI & Inflammation. Defines and leads global regulatory strategies to maximize success across complex programs, provides strategic and tactical guidance, and leads development of global regulatory plans with direct reports.

Responsibilities

• Defines strategies and provides tactical guidance to global regulatory teams; collaborates cross-functionally to ensure updated and executed global regulatory strategy and compliance.
• Leads Global Regulatory Teams (GRTs) and sub-working groups; represents GRTs at project team meetings; oversees direct reports or junior staff as needed.
• Ensures global regulatory strategies are implemented and maintained in response to changing regulatory and business needs; anticipates changes and leads adaptations.
• Maintains communication with project teams, management, and stakeholders regarding developments impacting regulatory success.
• Anticipates risks, develops solutions, and discusses them with team and management; assesses probabilities of technical success for solutions.
• Accountable for all US FDA submissions and approvals for projects; leads all submission types; collaborates with regional leads, vendors, and other functions to ensure compliant submissions.
• Direct point of contact with health authorities; leads FDA meetings; manages direct reports or junior staff as needed.
• Oversees vendor responsibilities for regulatory activities and submissions within scope; participates in or leads cross-functional task forces and initiatives.
• Leads due diligence for licensing opportunities; partners with global market access teams on interactions with regulatory/health agency/HTA bodies; monitors regulatory and access trends to shape development plans.
• Demonstrates Takeda leadership behaviors.

Qualifications

• Required: Bachelor‚Äôs Degree in a scientific discipline; 6+ years in pharmaceutical industry with 4+ years in regulatory experience; strong knowledge of drug development and regulatory requirements (FDA, EU, Canada, ROW, post-marketing).
• Preferred: Advanced degree (PharmD/PhD/MD); experience in reviewing, authoring, or managing regulatory submissions; ability to interpret complex scientific issues across multiple projects; strong communication, negotiation, and timeline management skills.
• Must work well with others and in global teams; ability to unite teams toward common objectives; proactive in identifying regulatory issues and proposing solutions, including risk mitigation.

Skills

• Regulatory strategy development and execution
• Cross-functional collaboration and leadership
• FDA submissions and health authority interactions
• Risk assessment and mitigation
• Scientific data interpretation for regulatory strategy
• Strong oral and written communication
• Project management and timeline adherence

Education

• Bachelor‚Äôs Degree in a scientific discipline (strongly preferred)
• Advanced degree (PharmD/PhD/MD) strongly preferred

Additional Requirements

• Hybrid work policy adherence is noted