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Job

Senior Manager Regulatory Affairs (Strategy)

  • Location

    New Jersey

  • Sector:

    Regulatory

  • Job type:

    Permanent

  • Salary:

    Competitive Salary + Benefits

  • Contact:

    Austin April

  • Contact email:

    a.april@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    Ref0015

  • Published:

    29 days ago

  • Expiry date:

    2018-05-23

  • Startdate:

    ASAP

Our client is looking for passionate regulatory affairs professionals with global regulatory strategy experience to join their regulatory affairs: oncology team in New Jersey. This role will be responsible for the design, support, and implementation of regulatory strategy to maximize the global approval of new medicinal products. 

This is an exciting opportunity to contribute to the planning, execution, and assessment  of product life cycle management and strategies at a global level. This role will involve working across multiple teams to organize resources and processes in order to complete regulatory submissions on time. In this role you will contibute to and implement strategy involving interactions with health authorities, as well as handle routine health authority communications. Other responsibilities include aiding in clinical development plans, global regulatory plans, and advising on US reglatory clinical trial and marketing authorization requirements with International Project Teams and Regulatory sub teams.  

Our client is looking for professionals with: 

  • BS/BA in the life sciences 
  • 8+ years pharmaceutical industry experience, with 4+ years related to new drug regulation product strategy and submissions 
  • Experience across the drug development process, involving work with international teams
  • Up to date knowledge of relevant drug laws, guidelines, and regulations
  • Experience in oncology desired 
  • Ability to take accountability and lead team discussions
  • Excellent written and oral communication skills