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.
- 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
Learn more at .
No Phone Calls or Recruiters Please.