Manager - CMC Submissions Management - Global Regulatory Affairs

5 days ago

Cambridge, United States Takeda 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. 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 Manager, Global Regulatory Affairs CMC Submission Management where you will support the execution of regulatory CMC investigational, registration and post-approval tasks for assigned products. Work in alignment with RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.


You will also prepare project plans and timelines for multiple CMC submission activities and be responsible for organization of CMC-related documents for regulatory submissions. Actively contribute to organizations planned initiatives and projects, lead and manage multiple and simultaneous projects. As part of the Regulatory Affairs CMC team, you will report to the Senior Manager GRA CMC and work with the GRA CMC organization.


How you will contribute:

  • With supervision, support in executing and managing regulatory tasks for assigned projects (IND/ IMPD/ CTA/ MAA) according to the regulatory strategy laid out by GRA.
  • Collaborating with cross-functional teams to develop project plans for global regulatory submissions (IND/ IMPD/ CTA/ MAA) and ensure alignment with business objectives and timelines.
  • Provide guidance to global project teams on submission processes, workflows, tools/ systems, filing strategy, eCTD document lifecycle management.
  • Participate to the creation of a submission content plans for assigned projects and monitors’ progress.
  • Plan, manage and track delivery of submission components, coordinate submission publishing activities with publishing team, organize submission review and approvals
  • Helps to define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
  • As a RA CMC member, ensures and/or enhances regulatory compliance.
  • Supports project team colleagues, line management, and key stakeholders are informed of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Works effectively with cross-functional teams beyond submission management role, contributing to broader organizational goals and initiatives while engaging in continuous improvement activities to enhance regulatory processes and outcomes leveraging innovative approaches and technologies.
  • Collaborates with AI specialists to develop and implement AI-based solutions for regulatory challenges, ensuring alignment with global standards and best practices.
  • Manages global Health Authority requests and ensure responses are submitted within the requested agency timeline.


Minimum Requirements/Qualifications:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
  • 4 years pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience. (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives required.
  • A good understanding of the drug development stages and strategy
  • Project management skills to oversee and coordinate various CMC activities
  • Working knowledge of tools (e.g., Publishing tools such as CTDxpress, Docubridge); Veeva RIM; global submission validation tools; Document Management systems.


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.


Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.


This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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