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Job

Senior Manager / Associate Director Regulatory Affairs

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    140k-190k

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2022-03-31

  • Startdate:

    ASAP

Senior Manager / Associate Director Regulatory Affairs

*Remote on East Coast, or Central Time Zone*

Responsibilities:

  • Provides regulatory strategic support and guidance across all functions
  • Coordinate with internal and external teams to author pre-clinical submissions, INDs, Clinical trial protocols, marketing applications, and other as needed regulatory applications, etc.
  • Assesses and communicates regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines
  • Supports and/or leads the planning and execution of global health authority interactions, including the generation and submission of briefing books and meeting preparations
  • Assists with and/or leads the planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, amendments, NDAs, and supplements within company timelines and in accordance with regulations and guidelines
  • Interprets and communicates health authority correspondence effectively and quickly to senior leadership and project teams

Experience:

  • 5 or more years of broad regulatory development experience in biotech/pharma industry
  • Working knowledge of prescription drug laws, ICH guidelines, regulations, and health authority guidances/guidelines
  • FDA interaction exp. needed, even if its just shadowing
  • EU experience highly preferred
  • Experience in oncology/rare disease preferred
  • Attention to detail with an ability to perform critical review of various types of documents
  • Outstanding communication skills and demonstrated ability to work as a team player on multi-disciplinary project teams

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