Manager, Global Regulatory Affairs - CMC Systems Oversight


  • Boston, MA
  • Permanent
  • Full-time
  • 1 month ago
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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Global Regulatory Affairs - CMC Systems Oversight in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Global Regulatory Affairs CMC team, you will be empowered to support the development and maintenance of systems and processes related to Change management, Regulatory Submissions, Post-marketing commitments and Clinical and commercial drug product supply, and a typical day will include:

  • Performs change assessments for multi-product changes
  • Supports compliance submissions, including Annual and Lot Distribution reports
  • Assists with quality system events requiring Regulatory CMC support (e.g. product quality annual reports, inspections and audits, deviations)
  • Represents GRA-CMC on cross-functional teams developing and maintaining Quality, Supply and regulatory systems
  • Responsible for developing and following GRA-CMC procedures in accordance with Global, GRA, Pharmaceutical Sciences and GMS/GQ policies and standards
  • Exercises good judgement in elevating and communicating actual or potential issues to line management.
Education, Behavioral Competencies and Skills
  • Demonstrates Takeda’s leadership behaviors
  • Understanding of change control, regulatory submission requirements required
  • Excellent written and oral communication skills required
  • BS/BA Degree in a Scientific Discipline minimum, Advanced Degree preferred
  • 3+ years pharmaceutical industry experience in a Quality-focused role (e.g. Production, Quality Assurance, Quality Control) desired
  • Ability to understand, apply, and articulate change management requirements for global drug development and post-market support desired
  • Demonstrates attention to detail, problem-solving abilities, and exercises appropriate judgment when working with project teams and individuals
  • Exercises good judgment in elevating and communicating actual or potential issues to line management.
  • Demonstrates ability to effectively manage competing priorities; works well in teams.
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
Empowering Our People to Shine

Learn more at .

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