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 Senior Manager, Global Regulatory Affairs, CMC in our Cambridge MA office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager, Global Regulatory Affairs, CMC working on the Global Regulatory Affairs team, you will be empowered to innovative and collaborative, and a typical day will include:
- With moderate supervision from RA CMC Management, develops and leads the execution of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle
- Develops comprehensive understanding of global RA CMC regulations and guidelines, and apply that knowledge to enhance probability of regulatory success or enhancing regulatory compliance
- Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly, with moderate supervision.
- Interacts with other internal and external colleagues, as well as with other functional areas and Alliance Partners.
- Plans, executes and manages regulatory submissions for assigned compounds with appropriate supervision from RA CMC Management.
- Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements, with appropriate oversight of RA CMC Management.
- With moderate supervision, represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
- Evaluates change proposals for regulatory impact and filing requirements
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 8 + years pharmaceutical Regulatory CMC experience. Alternatively 3+ years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired
- Some experience participating in meetings with Regulatory Agencies preferred.
- Ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives required.
- Demonstrates leadership, problem-solving abilities, and exercises appropriate judgment when working with project teams
- Exercises good judgment in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills required
- Active participation in Agency/Industry groups/forums preferred
- RAC certification desirable but not mandatory
- Routine demands of an office based environment.
WHAT TAKEDA CAN OFFER YOU:
- 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 takedajobs.com.
No Phone Calls or Recruiters Please.