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Job

Associate Director, Regulatory Affairs-Strategy

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Ryan Shaffer

  • Contact email:

    r.shaffer@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    8 months ago

  • Expiry date:

    2019-08-27

Currently seeking an 'Associate Director' to join the Regulatory Affairs team and support programs through Stage 1 and Stage 2. You will serve as the primary liaison with the FDA, working within the mAbs and small molecule departments.

 

Responsibilities:

  • Primary FDA liaison
  • Project management
  • Represent global regulatory team
  • Preparation of SOP’s

 

Requirements:

  • Master's, PhD or PharmD in scientific background
  • Expertise in Oncology, Immunology, or other Rare Disease
  • Previous experience working on a global scale (phase 1-2 preferred)
  • IND and DMF submission experience
  • Background in CMC

 

Please direct all questions to Ryan Shaffer at r.shaffer@hamlynwilliams.com or call 347-305-6781.