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.
Join Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
You will also communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development/due diligence activities. Proactively recognizes and contributes to enhancing business processes.
As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMS.
How you will contribute:
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.
Minimum Requirements/Qualifications:
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
10+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.
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.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.