Associate Director, Global Regulatory Affairs - GI & Inflammation

Role Summary

Associate Director, Global Regulatory Affairs - GI & Inflammation. Lead global regulatory strategies, provide strategic guidance to cross-functional teams, and oversee regulatory submissions and team development within a hybrid work environment.

Responsibilities

• Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
• Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
• Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
• Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings; defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed.
• Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs.
• Communicates developments that may impact regulatory success to project team colleagues, line management, and key stakeholders in a professional and timely manner.
• Proactively anticipates risks and develops solutions, discussing them with the team and management; understands probabilities of technical success for the solutions.
• Accountable for all US FDA submissions and approvals of projects of responsibility or oversees direct reports responsible; leads all submission types.
• Builds global regulatory strategies within the GRT and ensures their effective implementation and maintenance.
• Direct point of contact with health authorities, leads and manages FDA meetings; manages direct reports or junior staff as needed.
• Works with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations.
• Oversees vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates in or leads departmental and cross-functional task-forces and initiatives.
• Leads regulatory reviewer in due diligence for licensing opportunities.
• Partners with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable.
• Monitors and anticipates trends that impact regulatory and access environments to strengthen development plans and adopt regulatory strategies in a timely manner.
• Demonstrates Takeda leadership behaviors.

Qualifications

• Bachelor‚Äôs Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred
• 6+ years of pharmaceutical industry experience, including 4+ years of regulatory experience
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions
• Solid working knowledge of 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
• Strong oral and written communications, timeline management, negotiation skills, integrity and adaptability
• Independence in regulatory strategy with ability to identify issues and propose creative solutions and risk mitigation
• Collaborative work style with global teams; ability to align teams toward common objectives

Skills

• Regulatory strategy and leadership
• Global regulatory submissions (FDA and international)
• Cross-functional collaboration
• Risk assessment and mitigation
• Effective communication (oral and written)
• Project and team management

Education

• Bachelor‚Äôs degree in a scientific field; advanced degree (PharmD/PhD/MD) preferred

Additional Requirements

• Hybrid work arrangement as per policy