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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

How you will contribute:

This role is within in the R&D GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: 

• Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead. Assigned products include genetically modified cell therapies and other unique modalities

• Represents, contributes and influences Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development

• Demonstrate exceptional leadership and expert understanding of GRA CMC regulations and guidelines.  Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from vast prior experience, precedents and other regulatory intelligence beyond regulations.  Adept analytical and process understanding that enables the development of robust and accurate submissions

• Develops influential and constructive relationships and proactively communicates issues with clear recommendations to key internal and external colleagues, including Alliance Partners.  

• Successfully communicates and negotiates with International Health Authorities proven by track record – directly and indirectly. 

• Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges that arise during development and commercialization.  

• Coaches and develops people and teams, recruits and rewards to retain talent. Supports culture of high performance and trust, assures that the required level of knowledge and skills is available and identifies competency gaps. Establishes and implements effective development plans.

Accountabilities:

• Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.  

• Combines extensive knowledge of science and regulatory to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.  Proficiently leads overall product strategy with anticipation to future challenges.

• Represents or supervises representation at Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.

• Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required.

• Fosters constructive and influential working relationships when interacting with internal and/or external colleagues.  

• Providing strategic input into change control evaluation with a focus on consistent best practice and efficiencies.

• As a GRA CMC member, ensures and / or enhances regulatory compliance. 

• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judg