Director, Global Regulatory Affairs CMC

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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.

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

• Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.

• Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. 

• Demonstrate a high level of 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 prior experience, precedents and other regulatory intelligence beyond regulations. 

• Strong analytical or process understanding that enables the development of robust and accurate submissions

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

• Successfully communicates and negotiates with Health Authorities – directly and indirectly.

• Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization.

• Acts as mentor / coach to all GRA CMC members – as required.

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

• Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.  Ability to understand the overall product strategy and anticipate future challenges

• Represents 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 working relationships when interacting with internal and/or external colleagues. 

• Providing strategic input into change control evaluation - as required.

• 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 judgement and communicating in a professional and timely manner.  

• Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.

• When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities.

• Proactively identifies regulatory CMC risks, ensuring timely communication with line management.

• Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.

• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.

• Works…