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Job

Executive Director/VP Regulatory Affairs

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2022-01-02

  • Startdate:

    ASAP

Executive Director/Vice President of Regulatory Affairs

A clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. As a new member of Company team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Executive Director/Vice President of Regulatory Affairs will provide leadership, develop, monitor, and implement global regulatory strategies for the company pipeline. This includes leading interactions with health authorities, providing oversight and contributing to submission activities, and creating fit for purpose regulatory function processes. This position will report directly to EVP Clinical Development.

The Executive Director/Vice President of Regulatory Affairs will have the following specific responsibilities:

  • Establish the long-term strategy for the regulatory team and regulatory activities for Company pipeline.
  • Provide strong regulatory leadership in a cross-functional setting.
  • Ensure successful, timely and quality submissions to global health authorities.
  • Attract, empower, and retain talents; support the professional development of regulatory team members.
  • Oversee the development and implementation of fit for purpose, streamlined, and innovative systems, tools, and processes to enable submissions.
  • Develop regulatory strategic plans in collaboration with project teams. Generate regulatory submission plans, and direct document development, review, and finalization. Collaborate with team members to ensure agreed timelines and milestones are met.
  • Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review.
  • Effectively plan, organize, and conduct, in close collaboration with cross-functional team members, formal meetings with health authorities.
  • Independently plan, lead the preparation and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA and MAA applications and amendments or supplements.
  • Participate in or provide oversight to the review of critical documents such as protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
  • Ensure submissions to regulatory health authorities are complete, well-organized, of high quality, and compliant, working in concert with subject matter experts, and external vendors.
  • Provide interpretation of regulatory health authorities’ feedback, policies and guidelines
  • Serve as the liaison between the comapny and regulatory authorities.
  • Maintain up to date knowledge of FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.
  • Maintain an understanding and awareness of existing and evolving legislation and guidelines relevant to oncology and specific product areas that may affect company pipeline.
  • Keep current on the FDA OPDP environment and competitive products; communicate such information to the teams.
  • Perform and manage effective and timely regulatory intelligence and research, in support of regulatory affairs and oncology clinical development. Monitor current and evolving legislation regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios.
  • Ensure inspection readiness efforts for regulatory activities and files.
  • Manage regulatory budgets and vendors.

Required Experience, Skills, and Education:

  • B.S. in the sciences (advanced degree preferred), or health related field with a minimum of 15 years of increasing experience working in regulatory affairs within the pharmaceutical or biotechnology industry. S/he would have experience in preparation and submission of IND/CTA/NDA/MAA submissions with the regulatory agencies, and the ability to contribute to the submission of global regulatory applications.
  • A minimum of 5-10 years of cross-functional leadership and executive management experience.
  • Experience working on Phases 1-3 clinical trials in a global setting.
  • Oncology experience is required and early-stage oncology experience strongly desired.
  • Familiarity with the interpretation and application of relevant FDA guidelines pertaining to CMC, nonclinical and clinical matters in drug development.
  • Experience interacting directly with the FDA and other health authorities.
  • Proven ability to effectively work collaboratively in cross-functional teams and lead team discussions.
  • Must be highly detail-oriented, resourceful, and adaptable to effectively support multiple competing demands and changing priorities. Demonstrating effective prioritization and decision making.
  • Excellent problem-solving ability and organizational skills, while maintaining attention to detail. A high energy level, a willingness and ability to work in a hands-on capacity, to adapt and respond to a rapidly changing environment, and to work effectively in a project team environment.
  • Creative problem solving and strategizing abilities especially as it pertains to the regulatory requirements for complex filings.
  • The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.

This employer currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices.  Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law. 

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