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Job

Associate Director Regulatory Affairs

  • Location

    Remote

  • Sector:

    Life Sciences

  • Contact:

    Samuel Cantillo

  • Contact email:

    s.cantillo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    15 days ago

  • Expiry date:

    2021-11-11

  • Startdate:

    ASAP

Job Responsibilities:  

  • Work with 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 4 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 timelines.
  • Occasional travel required.

 

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