Posted to MedZilla HealthCare on 10/23/2018


Takeda Pharmaceuticals

US-MA, Senior Manager, Global Regulatory Affairs, CMC R0003415-MZ


 
 

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Job Description

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:

POSITION OBJECTIVES:

  • 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.

POSITION ACCOUNTABILITIES:

  • 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.

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Please visit our website at takedajobs.com

 
 


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