Senior Director, Global Regulatory Lead, GI & Inflammation

Senior Director, Global Regulatory Lead, GI & Inflammation

About the role:

The Global Regulatory Leads, Senior Director is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of bringing better health to people and a brighter future to the world.

How you will contribute:

• Ensure the organization is aware of and compliant with legislation and regulations pertaining to the business
• Monitor and interpret regulatory developments, determining the impact on business operations and compliance programs
• Implement compliance strategies and processes
• Prepare, review, and approve regulatory compliance documents for internal and external audiences
• Lead multiple teams of executives, directors/senior managers, and managers
• Ensure appropriate talent selection, organization, and leadership for major areas of the organization
• Engage with executive leadership on strategic matters and participate in product/business strategy development

Skills and qualifications:

• Expert in preparing and managing regulatory submissions with minimal guidance
• Skilled in analyzing complex data sets to derive actionable insights
• Proficient in leading project teams, demonstrating effective team management and leadership
• Experienced in interacting with government and approval authorities to facilitate regulatory processes
• Capable of representing the organization in high-stakes negotiations and discussions
• Able to mentor and develop junior staff, enhancing their skills and knowledge in regulatory affairs
• Strong strategic planner with a proven ability to anticipate and mitigate risks
• Excellent communication skills, capable of clearly conveying complex information

Accountabilities:

• The Senior Director will be responsible for complex or highly complex or multiple projects. 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, ensuring global regulatory compliance.
• Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or other staff responsible. The Senior Director will lead all submission types.
• Direct point of contact with health authorities, leads and manages FDA meetings and/or other regional HA meetings as appropriate. Manages direct reports or junior staff as needed.
• Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads 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 joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Responsible for demonstrating Takeda leadership behaviors.
• Bachelor’s Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline (Pharm
  
  D/PhD/MD) strongly preferred
• 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience.
• Experience in reviewing, authoring, or managing components of regulatory submissions.
• Expert knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post‑marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Understands and interprets scientific data as it relates to regulatory requirements and…