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Job

Manager/Senior Manager, Regulatory Affairs

  • Location

    Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    7 months ago

  • Expiry date:

    2022-01-31

  • Startdate:

    ASAP

Job Title:            Manager/Senior Manager, Regulatory Affairs

Job Location:     United States, (Homebased)

Job Duties and Responsibilities:

  • Provide regulatory guidance internally to project teams, functional areas and externally to clients.
  • Develop client regulatory plans including timelines, submission documentation, communication, and reporting and tracking of regulatory deliverables.
  • Maintain and develop regional and/or global strategic plans for the development of client drug product.
  • Prepare technical content for and review of regulatory documentation and submissions.
  • Liaise with regulatory authorities, clients, contractors, consultants and vendors.
  • Identify where regulatory specialty expertise is required or regions where local regulatory submission expertise is needed to meet project requirements.
  • Maintain effective internal and client project team communication to ensure quality, timeliness and within budget delivery of regulatory tasks.
  • Participate in internal and client project team meetings.
  • Participate in meetings with regulatory authorities.

Education and Experience

  • Bachelors’ degree in area of concentration commensurate with responsibility. Post-graduate degree and leadership role in academia or in pharmaceutical industry highly desirable.
  • 4+ years’ work experience commensurate with functional area of responsibility; or combination of work experience, education or other related industry experience in similar role.
  • Experience working in clinical research organizations is highly desirable

 

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