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 office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager working on the Global Regulatory Affairs, CMC team, you will be empowered to help develop innovative products for First-In-Human and early stage clinical studies (pre IND, Phase 1, Phase 2), and a typical day will include:
- As the RA CMC lead on Regulatory and Pharmaceutical Development project teams, develops and leads the execution of regulatory CMC development strategies for innovative First-In-Human and early stage products (pre IND, Phase 1, Phase 2), with minimal supervision.
- Develops and applies a comprehensive understanding of RA CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance.
- With some supervision, communicates and negotiates with Health Authorities as necessary, directly and indirectly.
- Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
- Plans, executes and manages regulatory submissions for assigned compounds in early phases of clinical development, with minimal supervision.
- As a RA-CMC lead, ensures and/or enhances regulatory compliance with respect to filing requirements.
- Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance.
- Represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters, with some supervision.
- Interacts directly with Health Authorities, as required.
- Ensures 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.
- Fosters constructive working relationships when interacting with internal and/or external colleagues.
- Evaluates change proposals for regulatory impact.
EDUCATION, EXPERIENCE, BEHAVIORIAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 6+ years pharmaceutical Regulatory CMC experience, including experience as an RA CMC product lead, 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.
- Proven ability to provide strategic regulatory guidance to drug development teams. Experience developing First-In-Human initial INDs/IMPDs preferred.
- Able to deal with issues of critical importance with minimal supervision. Provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
- Exercises good judgement 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.
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.