Senior Director, Global Regulatory Lead, GI & Inflammation

Role Summary

Senior Director, Global Regulatory Lead, GI & Inflammation. Defines, develops and leads global regulatory strategies to maximize regulatory success across complex programs; provides strategic and tactical guidance to ensure timely and compliant development and maintenance of programs; leads and develops a team of global regulatory leads and collaborates with regional counterparts.

Responsibilities

• Lead Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs at project team meetings; define strategies and provide tactical guidance to ensure global regulatory strategy is updated and executed with compliance.
• Ensure global regulatory strategies are effectively implemented and maintained; anticipate changes and adapt regulatory strategy accordingly.
• Keep project team colleagues, line management, and key stakeholders informed of developments impacting regulatory success; communicate professionally and timely.
• Anticipate risks and develop solutions; discuss with team and management; assess probabilities of technical success for solutions.
• Accountable for all US FDA submissions and approvals for projects of responsibility; lead all submission types; manage direct reports as needed.
• Act as direct point of contact with health authorities; lead FDA meetings and regional HA meetings as appropriate; manage junior staff as needed.
• Collaborate with regulatory regional leads, other functions and vendors to ensure global submissions comply with local regulations and maintain product compliance.
• Oversee vendor responsibility 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 and anticipate regulatory and access environment trends to strengthen product development plans and timely regulatory strategies.
• Demonstrate Takeda leadership behaviors.

Qualifications

• Bachelor’s Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
• 12+ years of pharmaceutical industry experience, including 10 years of regulatory experience or a combination of 8+ years regulatory and related experience
• Experience in reviewing, authoring, or managing regulatory submissions
• Expert knowledge of drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW and post-marketing a plus
• Ability to interpret complex scientific issues across multiple projects related to regulatory requirements and strategy
• Ability to interpret scientific data for regulatory strategy and guide team in building regulatory strategy
• Strong oral and written communication, time management, negotiation skills, integrity and adaptability
• Independence in regulatory strategy with ability to identify issues and develop creative solutions including risk mitigation
• Ability to work well with others and within global teams; capability to lead cross-functional teams toward common objectives

Skills

• Regulatory strategy development and execution
• Global regulatory submissions and negotiations
• FDA and global health authority engagement
• Cross-functional leadership and stakeholder management
• Risk assessment and mitigation
• Strategic thinking and problem solving
• Scientific and regulatory knowledge across multiple projects

Education

• Bachelor’s Degree in a scientific discipline (required or strongly preferred)
• Advanced degree (PharmD/PhD/MD) strongly preferred

Additional Requirements

• None specified beyond standard regulatory leadership responsibilities