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 - Marketed Products 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 - Marketed Products team, you will be empowered to develop and lead the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products, and a typical day will include:
- Regulatory Affairs CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
- Develops and applies a comprehensive understanding of global RA CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance.
- With moderate supervision, successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
- Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
- With minimal supervision, plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- As a RA CMC product leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
- Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- 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.
- Interacts directly with international 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 global regulatory impact. and plans global variations and amendments.
EDUCATION, BEHAVIOURAL 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 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 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.
- Routine demands of an office based environment.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
*expectation for travel may depend on the projects to be supported
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.