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Senior Director, Regulatory Affairs

  • Location

    D.C. Metro Area, United Kingdom

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    $180,000 - $220,000

  • Contact:

    Callum Sparkes

  • Contact email:

    callum.sparkes@catalystcareers.com

  • Job ref:

    60275

  • Published:

    3 months ago

  • Expiry date:

    2021-09-10

  • Consultant:

    Callum Sparkes

This is an opportunity for someone with a proven track record of regulatory strategy leadership to join a high growth public company in the immunology and oncology space, and have a significant impact on the strategy for upcoming submissions. With both public investment and big bio-pharma partnerships, there is a lot of hype around this organisation's future within the immuno-oncology space.

Core Responsibilities
  • Lead the strategy for ongoing and upcoming regulatory submissions (IND, CTAs and NDAs/BLAs) with products currently going through promising clinical trials
  • Act as point of contact for Regulatory Agencies between US and global teams;
  • Develop, review and complete submission documents in collaboration with other functional disciplines.
  • Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders.
  • Participate in the development and implementation of short- and long-term Regulatory plans for key projects;
  • Guide Nonclinical, CMC and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs;
  • Lead preparations and delivery of FDA communications with Clinical Development Teams
Qualifications/Education required to be considered
  • Minimum of a Bachelor’s Degree in an applied science field. Ph.D degree is highly preferred.
  • 10+ years' Regulatory Affairs experience in drug development and/or registration activities is a must.
  • Proven track record of successful strategy leadership and management within a regulatory function.
Please be advised that only those who do not require sponsorship are able to be considered at this point.