Associate Director, Global Regulatory Affairs, Inflammation

Takeda•Cambridge, MA

3d•$154,400 - $242,550•Hybrid

About The Position

The Associate Director, Global Regulatory Affairs, Inflammation defines, develops, and leads global regulatory strategies to maximize regulatory success and achieve program objectives for complex or multiple projects. The role provides strategic and tactical guidance to project teams to support timely and efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements. The Associate Director also contributes as a leader within the department and R&D, including through cross-functional initiatives and influence in the field. The position is accountable for building, implementing, and maintaining global regulatory strategies in collaboration with the Global Regulatory Team (GRT), adapting strategies to changing regulatory and business needs. It provides guidance to teams, anticipates and addresses risks, communicates important developments to stakeholders, and is accountable for US FDA submissions and approvals for assigned projects. The role serves as a direct point of contact with health authorities and leads and manages FDA meetings. It also works with regional regulatory leads, other functions, vendors, and local Takeda affiliates to support compliant global submissions and ongoing product compliance. The Associate Director may oversee direct reports or junior staff and vendor activities, and may lead or influence departmental and cross-functional initiatives. The position is classified as hybrid under Takeda’s Hybrid and Remote Work policy. It is a regular, full-time employee position based in Cambridge, Massachusetts.

Requirements

At least 6 years of pharmaceutical industry experience, including at least 4 years of regulatory experience.
Strong working knowledge of the drug development process and regulatory requirements.
Ability to 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 skills.
Ability to work effectively with others and within global teams, and bring working teams together around common objectives.
Increasingly independent regulatory strategy skills, including identifying regulatory issues, understanding organizational and global implications, and proposing creative strategies and risk-mitigation solutions.

Nice To Haves

Advanced degree in a scientific discipline, such as PharmD, PhD, or MD, is strongly preferred.
Experience reviewing, authoring, or managing components of regulatory submissions is preferred.
Knowledge of FDA, EU, Canada, rest-of-world, and post-marketing regulatory matters is a plus.

Responsibilities

Define, develop, and lead global regulatory strategies for complex or multiple projects to support program objectives and maximize regulatory success.
Provide strategic and tactical guidance to project teams to facilitate timely, efficient development and maintenance of programs in compliance with regulatory requirements.
Collaborate with the Global Regulatory Team (GRT) to build, implement, and maintain global regulatory strategies, anticipating and adapting to changing regulatory and business needs.
Keep project team colleagues, line management, and key stakeholders informed of developments that may affect regulatory success.
Anticipate regulatory and project risks, develop solutions and risk-mitigation approaches, and discuss them with teams and management.
Be accountable for US FDA submissions and approvals for assigned projects, or oversee direct reports responsible for them.
Serve as a direct point of contact with health authorities and lead and manage FDA meetings.
Work with regional regulatory leads, other functions, vendors, and local Takeda affiliates to ensure global regulatory submissions comply with local regulations and products remain compliant.
Oversee vendor responsibility for regulatory activities and submissions within the assigned projects.
Manage direct reports or junior staff as needed.
Participate with influence in, or lead, departmental and cross-functional task forces and initiatives.
Demonstrate Takeda leadership behaviors.