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Job

Manager - Regulatory Affairs Strategy

  • Location

    Boston, Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    $150,000 - $165,000

  • Contact:

    Ryan Burton

  • Contact email:

    r.burton@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-09-16

  • Startdate:

    8/30/2021

Hamlyn Williams is partnered with an exciting, publicly traded, Clinical-Stage biotech with over 20 products in the pipeline. The company develops treatments for Rare Diseases, Oncology, and Vaccines and they are looking to hire a Manager-level Regulatory Affairs professional to report directly to the Head of Regulatory Affairs. With one product moving into approval, the company will be commercialized within the next few months.

Job Responsibilities:

  • Participate as a critical thinking member of the Regulatory Affairs team to establish development and regulatory strategies for early-stage and late-stage development programs.
  • Collaborate with cross-functional teams such as CMC, clinical, labeling, and post-approval, representing and coordinating regulatory information
  • Liaise with EU, Canadian, and US Health Authorities
  • Prepare IND, NDA, CTA, and BLA submissions including original marketing applications, amendments, supplements, variations, responses to Health Authority questions and requests, briefing packages, annual reports, periodic safety reports, etc.
  • Participate in the electronic review and quality verification of regulatory submissions
  • Ensure adherence to regulations and applicable guidelines for all regulatory submissions
  • Provide risk assessments and recommendations for various regulatory scenarios

Requirements:

  • Bachelor's degree required; Advanced degree preferred
  • Minimum of 3 years of regulatory strategy experience within the pharmaceutical or biotechnology environment
  • Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
  • Excellent verbal and written communication skills
  • Ability to work with limited supervision, to set priorities to meet timelines
  • Some travel will be required

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