Senior Manager, Global Regulatory Affairs CMC

Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 9, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Senior Manager, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. You will also with moderate guidance, communicate and negotiate with international Health Authorities, directly and indirectly. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.How you will contribute:

• Plan and execute regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
• As a GRA CMC product leader or team member, ensures and enhances regulatory compliance for filing requirements for assigned compounds throughout development and the commercial life cycle.
• Independently define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
• With moderate guidance, represents Takeda RA CMC in Health Authority meetings and leads CMC preparation activities for meetings with Health Authorities on CMC related matters.
• Interact directly with international Health Authorities.
• Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success.
• Foster constructive working relationships when working with all colleagues.
• Evaluate change proposals for global regulatory impact. and plans global variations and amendments.What you bring to Takeda:
  • 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.
  • Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
  • Able to deal with issues of essential importance. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
  • Demonstrate new leadership, problem-solving ability, attention to detail, flexibility and values teamwork.
  • Exercise good judgement in elevating and communicating actual or potential issues to line management.
  • Excellent written and oral communication skills.
  • Active participation in Agency/Industry groups/forums preferred.What Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • 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 and company match of charitable contributions
    • Family Planning Support
    • Flexible Work Paths
    • Tuition reimbursementThis position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.In accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering our people to shine:Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.No Phone Calls or Recruiters Please.#LI-LC1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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