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Senior Manager, Global Regulatory Affairs CMC

Company: Takeda Pharmaceutical
Location: East Orange
Posted on: September 14, 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 DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as -an Senior Manager, Global Regulatory Affairs CMC based -in Zurich, Switzerland or Vienna, Austria. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVE:

  • With supervision, develops and leads the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. RA 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.ACCOUNTABILITIES:
    • 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.WHAT TAKEDA CAN OFFER YOUAt Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering Our People to ShineDiscover more at takedajobs.comAt our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have? LocationsCHE - Glattpark (Opfikon) - Zurich HQAUT - Wien - DC TowerWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, East Orange , Senior Manager, Global Regulatory Affairs CMC, Executive , East Orange, New Jersey

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