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Job

Regulatory Affairs Strategy Lead - Oncology

  • Location

    Remote, USA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Ryan Burton

  • Contact email:

    r.burton@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    HQ0002703

  • Published:

    4 months ago

  • Expiry date:

    2021-07-14

  • Startdate:

    July 1st (ASAP)

Hamlyn Williams Life Sciences is partnered with an exciting, clinical-stage biotech, looking to hire a Regulatory Affairs Lead with Global Regulatory experience (EU, Health Canada, and FDA preferred). The successful candidate will be based remotely, with the opportunity to travel once per month/quarter for key meetings.

Job Responsibilities:

  • Participate as a critical thinking member of the Regulatory Affairs team to establish development and regulatory strategies for early-stage and late-stage development programs.
  • Collaborate with cross-functional teams such as CMC, clinical, labeling, and post-approval, representing and coordinating regulatory information
  • Liaise with EU, Canadian, and US Health Authorities
  • Prepare IND, NDA, CTA, and BLA submissions including original marketing applications, amendments, supplements, variations, responses to Health Authority questions and requests, briefing packages, annual reports, periodic safety reports, etc.
  • Participate in the electronic review and quality verification of regulatory submissions
  • Ensure adherence to regulations and applicable guidelines for all regulatory submissions
  • Provide risk assessments and recommendations for various regulatory scenarios

Requirements:

  • Bachelor's degree required; Advanced degree preferred
  • Minimum of 5-10 years of regulatory strategy experience within the pharmaceutical or biotechnology environment
  • Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
  • Excellent verbal and written communication skills
  • Ability to work with limited supervision, to set priorities to meet timeline