Director, GRA CMC Small Molecules

4 weeks ago

Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time
About the Role

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Director, GRA CMC Small Molecules, you will oversee the development and execution of regulatory CMC development and registration strategies. You will be responsible for leading cross-functional teams and providing regulatory CMC expertise for new business development/due diligence activities.

Key Responsibilities
  • Independently plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
  • Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.
  • Lead team members that defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
  • Lead and/or contribute to business process development and enhancement.
  • Evaluate new business development opportunities or participate on due diligence teams.
  • Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
  • Responsible for ensuring that 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.
  • Exercise good judgement in elevating and communicating actual or potential issues to line management.
  • Communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
  • Represent Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
  • Interact directly with international Health Authorities, as required.
  • Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
  • Manage and develops staff, if required, including staff professional development and project oversight accountability.
  • Evaluate change proposals for regulatory impact and filing requirements.
Requirements
  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead with late stage development, international experience strongly preferred.
  • Significant Small Molecule experience.
  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
  • Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
  • Demonstrates leadership, problem-solving ability, flexibility and teamwork.
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
  • Willingness to travel to various meetings, including overnight trips.
  • Requires approximately up to 10-30% travel.

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