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Job

Senior Manager/Associate Director, Regulatory Affairs Strategy

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2021-10-24

  • Startdate:

    ASAP

​Responsibilities:

  • Serves as a liaison to the FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provide oversight to regulatory consultants and vendors where applicable
  • Provides regulatory strategic support and guidance across all functions
  • Routinely performs regulatory precedence and competitive intelligence research
  • Contributes to identification of potential issues/gaps and proposes creative risk-mitigation strategies to address gaps affecting optimal and timely submission and approval
  • 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:

  • BS/BA in a relevant field required; advanced degree preferred (PharmD, MD, PhD)
  • 5 or more years of broad regulatory development experience in biotech/pharma industry, including 3 or more years of new drug regulated product strategy/submissions
  • Working knowledge of prescription drug laws, ICH guidelines, regulations, and health authority guidances/guidelines
  • Experience in oncology/rare disease preferred

 

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