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Job

Senior Director Regulatory Affairs

  • Location

    Remote

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Andrea Fratus

  • Contact email:

    a.fratus@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    28 days ago

  • Expiry date:

    2022-06-25

  • Startdate:

    ASAP

This newly created leadership role will provide regulatory leadership and develop regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally. This Executive / Senior Director (level based on experience) will also provide life cycle management and maintain compliance with applicable regulatory requirements. This leader will support business development activities and serve as a regulatory expert as part of cross-functional diligence teams to assess external assets/opportunities. This person will act as a resource to the broader regulatory function, including mentorship of team members.

What you will do:

  • Provide strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success.
  • Interpret and apply regulations in the creation of timely and innovative regulatory strategies for US and international markets.
  • Represent the regulatory function on cross-functional development teams.
  • Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications including Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), and Marketing Authorization Application (MAA).
  • Work with regulatory submissions coordinators to develop submission timelines and work with cross-functional teams to planned objectives.
  • Serve as the primary point of contact with Regulatory Authorities and develop strong working relationships with counterparts of FDA, EMA, and other regulatory authorities.
  • Interact with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions.
  • Manage all maintenance plans for regulatory investigative and marketing applications for assigned projects.
  • Act as regulatory expert for diligence of external assets as part of business development activities.
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
  • Provide regulatory guidance and/or training to external departments.
  • Prepare and revise internal procedures for continuous improvement.

    We’d love to hear from you if:

  • You possess an advanced degree in life sciences, preferably a PhD or PharmD
  • You bring at least 8 years of progressive experience in regulatory affairs management in the pharmaceutical/biotechnology for Senior Director consideration; you bring at least 12 years of progressive experience for Executive Director consideration
  • You have served in a leadership role for at least 3 years
  • You bring experience in targeted oncology drug development; experience in companion diagnostics, biologics or other related therapeutic areas will be considered
  • You know US and international regulations as they apply to pharmaceutical and biologic drug development
  • You bring experience managing development of INDs and other global clinical trial applications
  • You are experienced in managing the development of NDAs/MAAs
  • You bring considerable experience leading regulatory agency interactions, ideally including Advisory Committees or Scientific Advice procedures
  • You have full lifecycle experience from early development to managing marketed products, preferably oncology
  • You are an excellent communicator, skilled negotiator, and team-oriented leader
  • You are proficient at creating and communicating a clear vision among team members