Regulatory Affairs Manager

  • Location
    Basking Ridge, New Jersey
  • Job Type:
    Direct Hire
  • Job reference:
    US_EN_8_842895_2853951

We are directly working with the VP of Business Development for a global Pharmaceutical company, based in Basking Ridge NJ. They are looking to bring on a dynamic Regulatory Affairs Manager or Senior Manager to join their team.

RESPONSIBILITIES:

  • Create, organize and manage the preparation of all types of FDA submissions including post approval changes and PLAIRs.
  • Preparation and submission of the requisite Annual Reports, and PADERS for approved ANDA's.
  • Responsible for implementing life-cycle remediation techniques and creating baseline submissions for applications with damaged eCTD life-cycles.
  • Other responsibilities include ANDA Applications, Annual Reports, and Annual/Quarterly PADERs.
  • REQUIREMENTS:

  • 5-7 years of Pharma/ Bio-tech experience with 3+ years in Regulatory Affairs
  • Knowledge of filing and approval process for generic drug products
  • Experience writing and assembling the supporting documentation for ANDAs and other regulatory filings, including familiarity with CTD format and eCTD submissions.


  • Equal Opportunity Employer/Veterans/Disabled

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    The Company will consider qualified applicants with arrest and conviction records