Associate Director, Global Regulatory Affairs - GI & Inflammation

Role Summary

Associate Director, Global Regulatory Affairs - GI & Inflammation. Defines, develops and leads global regulatory strategies to maximize regulatory success across complex programs; provides strategic and tactical guidance to teams; leads and develops direct reports in global regulatory strategy and execution.

Responsibilities

• Define strategies and provide tactical guidance to Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs at project team meetings; collaborate cross-functionally to ensure global regulatory strategy is updated and executed.
• Ensure global regulatory strategies are implemented and maintained in line with evolving regulatory and business needs; lead adaptations as required.
• Keep project teams, line management, and key stakeholders informed of regulatory developments affecting success; communicate professionally and timely.
• Proactively identify risks, develop solutions, discuss with team and management; assess probabilities of technical success for proposed solutions.
• Accountable for US FDA submissions and approvals for projects of responsibility; lead all submission types; oversee direct reports as needed.
• Build global regulatory strategies within the GRT and ensure effective implementation and maintenance.
• Serve as direct point of contact with health authorities; lead FDA meetings; manage direct reports as needed.
• Collaborate with regulatory regional leads, other functions, and vendors to ensure compliant global submissions to local Takeda affiliates.
• Oversee vendor responsibilities for regulatory activities and submissions within scope.
• Participate in or lead departmental and cross-functional task-forces and initiatives.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with regulatory/health agency/HTA bodies on product-specific value evidence topics.
• Monitor regulatory and access environment trends; adapt product development plans and regulatory strategies accordingly.
• Demonstrate Takeda leadership behaviors.

Qualifications

• 6+ years of pharmaceutical industry experience, including 4+ years in regulatory affairs.
• Bachelor‚Äôs degree in a scientific discipline; advanced degree (PharmD/PhD/MD) strongly preferred.
• Preferred experience reviewing, authoring, or managing components of regulatory submissions.
• Solid knowledge of drug development processes and regulatory requirements (FDA, EU, Canada, ROW, post-marketing knowledge a plus).
• Ability to interpret complex scientific issues and data for regulatory strategy; strong written and oral communication; strong timeline management; negotiation skills; integrity and adaptability.
• Ability to work effectively with global teams and bring teams together for common objectives.

Skills

• Regulatory strategy development and execution
• Cross-functional leadership and stakeholder management
• FDA regulatory submissions and meetings
• Risk assessment and mitigation
• Global regulatory intelligence and trend analysis
• Excellent communication and negotiation skills

Education

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