Director, Global Regulatory Lead, GI & Inflammation

Role Summary

Defines, develops and leads global regulatory strategies to maximize regulatory success across complex and/or multiple projects. Provides strategic and tactical guidance to teams to ensure timely development and maintenance of programs in compliance with regulatory requirements. Serves as a department and R&D leader, contributing to cross-functional initiatives and influencing the field, and leads leadership and development for direct reports responsible for global regulatory strategies in collaboration with regional counterparts.

Responsibilities

• Lead the Global Regulatory Teams (GRTs) and sub-working groups; represent GRTs at project team meetings; define strategies and provide tactical guidance to ensure updated, compliant global regulatory strategies.
• Implement and maintain global regulatory strategies in response to changing regulatory and business needs; anticipate changes and adapt strategies accordingly.
• Keep project teams, management, and stakeholders informed of developments that may impact regulatory success; communicate professionally and timely.
• Proactively identify risks and develop solutions; discuss risk management with team and management; assess probabilities of technical success for solutions.
• Accountable for US FDA submissions and approvals for projects of responsibility or oversee direct reports; lead all submission types.
• Build and maintain global regulatory strategies within the GRT; ensure effective implementation across the organization.
• 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 timely global regulatory submissions to local affiliates in compliance with local regulations.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participate in or lead departmental and cross-functional task-forces and initiatives.
• Lead regulatory review 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 as applicable.
• Monitor and anticipate trends impacting regulatory and access environments to strengthen product development plans and adapt regulatory strategies accordingly.
• Demonstrate Takeda leadership behaviors.

Qualifications

• Bachelor’s Degree in a scientific discipline (strongly preferred)
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
• 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 4+ years regulatory and/or related experience
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions
• Solid working knowledge of the drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW, and post-marketing a plus
• Ability to understand and interpret complex scientific issues across multiple projects as they relate to regulatory requirements and strategy
• Ability to interpret scientific data as it relates to regulatory requirements and strategy; provide guidance for regulatory strategy
• Strong oral and written communications, ability to manage timelines, negotiation skills, integrity and adaptability
• Demonstrates increasing independence in regulatory strategy; proactively identifies issues and offers creative solutions and risk mitigation strategies
• Strong collaboration skills; ability to work well with global teams and bring teams together for common objectives
• Independent skills in regulatory strategy with broad understanding of regulatory affairs and global implications

Education

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

Skills

• Regulatory strategy development and execution
• Global regulatory submissions and health authority interactions
• Cross-functional leadership and team development
• Risk assessment and mitigation
• Strategic communication and stakeholder management
• Regulatory knowledge across FDA, EU, Canada, and other regions