Director - GRA CMC, Small Molecules

20 hours ago


Cambridge, United States Takeda Full time

Job Description


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.



  • Cambridge, Massachusetts, United States Biogen Full time

    Job SummaryWe are seeking a highly experienced Regulatory CMC Team Lead to lead our small molecule portfolio. As a key member of our Regulatory CMC team, you will be responsible for the line management of direct reports, defining regulatory CMC strategy, and planning and preparing global CMC regulatory submissions.Key ResponsibilitiesAccountable for line...


  • Cambridge, Massachusetts, United States Takeda Full time

    Job DescriptionTakeda is a global pharmaceutical company committed to delivering innovative therapies to patients worldwide. We are seeking a highly skilled Director, GRA CMC Small Molecules to join our team.Key ResponsibilitiesDevelop and execute regulatory CMC development and registration strategies for assigned products.Lead cross-functional teams to...


  • Cambridge, United States Intellia Therapeutics Full time

    Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    About the RoleWe are seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team at Agios Pharmaceuticals. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and contributing to the overall CMC strategy...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Role SummaryAgios Pharmaceuticals is seeking a highly motivated Associate Director, Analytical Development, CMC to join our growing CMC team. The ideal candidate will be a key stakeholder within analytical development team to help build and lead the analytical development function within CMC and hands-on contributor to the overall CMC strategy of drug...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    About the RoleAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and contributing to the overall CMC strategy of drug...


  • Cambridge, Massachusetts, United States Takeda Full time

    About the Role:We are seeking a highly experienced Senior Director, Regulatory Affairs CMC to join our team at Takeda. As a key member of our Regulatory Affairs CMC team, you will be responsible for establishing collaboration with Global CMC teams and leadership through networks and enabling CMC regulatory team's success in meeting goals/objectives.Key...


  • Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time

    About the RoleWe are seeking an experienced Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team within Technical Operations. As a key member of our team, you will be responsible for developing and transforming genome editing development candidates into therapeutic products.Key ResponsibilitiesCoordinate and support...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionTakeda is seeking a Senior Director and Regulatory Platform Lead for CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for pure device and combination product submissions, with a focus on...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job OverviewWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda Pharmaceutical. This role will be responsible for leading the development and implementation of innovative regulatory strategies for CMC, Device and Drug-Device Combinations Material Sciences.Key ResponsibilitiesDevelop and implement...


  • Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.Your RoleDevelop and execute CMC global submission plans and...


  • Cambridge, United States Takeda Pharmaceutical Full time

    Job DescriptionTakeda Pharmaceutical is seeking a highly experienced and skilled Senior Director and Regulatory Platform Lead to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination product development.Key...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Job Summary:We are seeking a highly motivated and experienced Senior Analytical Development Manager, CMC to join our growing CMC team at Agios Pharmaceuticals. The successful candidate will be responsible for leading the analytical development function within CMC and contributing to the overall CMC strategy of drug development at Agios.Key Responsibilities:...


  • Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...


  • Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Lead Analytical Development at Agios PharmaceuticalsAgios Pharmaceuticals is a biopharmaceutical company that empowers connections, fostering a supportive, fun, and flexible environment where employees thrive. We care deeply about our work, each other, and the patients who rely on us. We cultivate strong bonds with patient communities, healthcare...


  • Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time

    About the Role: We are seeking a highly skilled Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team at Intellia Therapeutics. As a key member of our Technical Operations department, you will be responsible for developing and transforming genome editing development candidates into therapeutic products. As the Product...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionAt 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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.Key...


  • Cambridge, Massachusetts, United States Relay Therapeutics Full time

    The OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...


  • Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time

    About Intellia Therapeutics, Inc.Intellia Therapeutics, Inc. is a biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to transform the lives of people living with these conditions by leveraging the power of genome editing.Job SummaryWe are seeking an experienced Associate...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionTakeda Pharmaceutical is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory...