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Sr. Director, Regulatory Affairs

Company: Ascent Services Group
Location: Mountain View
Posted on: April 2, 2021

Job Description:

Sr. Director, Regulatory Affairs,
The Senior Director will serve as a Regulatory leader who defines and implements Regulatory strategy for pre- and post-approval product(s). This is an exciting opportunity for someone who wants to marry their late stage development experience with labeling and life-cycle management activities.
The Senior Director must be an independent decision maker who can lead and oversee assigned global regulatory interactions and filings, including label negotiations, and follow-on indications.

Responsibilities:

  • Prepare, submit and maintain regulatory files (NDAs, supplemental NDAs, etc.) for approved products
  • Interact with regulatory agencies to optimize labeling
  • Review marketing promotional materials and provide leadership/guidance in the development of compliant sales training, advertising and detail literature
  • Advise Medical Liaison and Medical Communications groups regarding regulatory issues and impacts of these activities
  • Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA
  • Provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives, timelines and budgets
  • Contribute hands on support in managing, planning, coordinating, and preparing all documents submitted to FDA and other Health Authorities in support of INDs, MAAs, CTAs, amendments, safety reports, and annual updates
  • Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
  • Set direction and focus by leveraging organizational abilities and proactive planning
  • Establish and develop regulatory policies, procedures and best practices commensurate with the requirements of a rapidly growing company
    Qualifications:
    • BS Required. Advanced degree is preferred (MS/PhD/PharmD)
    • 10+ years regulatory affairs in bio/pharma industry
    • Strong knowledge of FDA regulations and EU CTA requirements
    • Delivery of major global applications (NDA/MAA/JNDA etc.) and lead role preferred.
    • Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
    • Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, PSURs, IMPD's, and Briefing packages and other regulatory submissions required
    • Experience interacting/negotiating with regulatory authorities (e.g. FDA, EMA, etc.)
    • Thorough understanding of regulatory labeling requirements and strategic labeling planning.
    • Work with diverse stakeholders and build strong, collaborative relationships; manage competing agendas and priorities across different functional department
    • Excellent oral communication and writing skills Job Type: Direct Placement
      Location: Mountain View, CA
      Job ID: 21-01924
      Date Updated: March 2, 2021 Melissa Meyer is recruiting for this position. Corporate Office
      1001 Galaxy Way, Suite 405
      Concord, CA 94520
      925-627-4900
      info@ascentsg.com Employment Verifications
      Via The Work Number, employer code 105779 Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.

Keywords: Ascent Services Group, Mountain View , Sr. Director, Regulatory Affairs, Executive , Mountain View, California

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