Director, Global Regulatory Lead, GI & Inflammation

Takeda•Boston, MA

4d•$177,000 - $278,080•Hybrid

About The Position

The Director, Global Regulatory Lead for GI & Inflammation defines, develops, and leads global regulatory strategies to maximize regulatory success for complex or multiple projects. The role provides strategic and tactical guidance to support timely, efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements. The Director is a leader within the department and R&D, contributes to cross-functional initiatives, and provides leadership and development for direct reports, including global regulatory leads. The Director leads Global Regulatory Teams and relevant sub-working groups, represents those teams at project meetings, and collaborates across functions to define, update, and execute global regulatory strategies. The role is accountable for US FDA submissions and approvals, leads FDA meetings and other health-authority interactions, and works with regional regulatory leads, affiliates, functions, and vendors to support compliant global submissions and product maintenance. It also anticipates regulatory and access trends, develops solutions to risks, participates in departmental and cross-functional initiatives, conducts regulatory due diligence for licensing opportunities, and partners with market access colleagues on applicable joint regulatory, health-agency, and HTA interactions. The position is classified as hybrid under Takeda’s Hybrid and Remote Work policy and is based in Boston, Massachusetts. The stated U.S. base salary range is $177,000 to $278,080.

Requirements

Bachelor’s degree; a scientific discipline is strongly preferred.
At least 8 years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 4 or more years of regulatory and/or related experience.
Solid working knowledge of the drug development process and regulatory requirements.
Ability to understand and interpret complex scientific issues and data across multiple projects in relation to regulatory requirements and strategy.
Strong oral and written communication, timeline management, negotiation, integrity, and adaptability.
Ability to identify regulatory issues proactively and develop creative strategies and risk-mitigation solutions with increasing independence.
Ability to work effectively with others and within global teams, and to bring working teams together around common objectives.

Nice To Haves

Advanced scientific degree (PharmD, PhD, or MD) strongly preferred.
Experience reviewing, authoring, or managing components of regulatory submissions.
Knowledge of FDA, EU, Canada, rest-of-world, and post-marketing requirements.

Responsibilities

Define, develop, and lead global regulatory strategies for complex or multiple projects.
Lead Global Regulatory Teams and applicable sub-working groups, such as the Label Working Group, and represent them at project team meetings.
Provide strategic and tactical guidance to teams and collaborate cross-functionally to execute and maintain global regulatory strategies.
Ensure regulatory strategies adapt to changing regulatory and business needs and maintain global regulatory compliance.
Keep project colleagues, line management, and key stakeholders informed of developments that may affect regulatory success.
Anticipate regulatory risks, develop solutions, and discuss risks and solutions with teams and management.
Lead or oversee US FDA submissions and approvals, including all submission types for assigned projects.
Serve as a direct point of contact with health authorities and lead and manage FDA meetings.
Work with regional regulatory leads, other functions, and vendors to provide global submissions to local Takeda affiliates in compliance with local regulations and maintain product compliance.
Oversee vendor regulatory activities and submissions for projects within scope.
Participate with influence in or lead departmental and cross-functional task forces and initiatives.
Serve as lead regulatory reviewer in due diligence for licensing opportunities.
Partner with global market access colleagues on applicable interactions with joint regulatory, health-agency, and HTA bodies regarding product-specific value evidence topics.
Monitor and anticipate trends affecting regulatory and access environments to strengthen product development plans and adapt regulatory strategies.
Provide leadership and development for direct reports and manage direct reports or junior staff as needed.
Demonstrate Takeda leadership behaviors.