Regulatory Affairs Manager

Bridgewater, NJ
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 134001

Date Posted: 12/12/2018


Title: Regulatory Affairs Manager

Location:  Bridgewater, NJ

Duration: Permanent

Requirements:

  • Bachelor’s Degree in related field or equivalent experience required; Advanced Degree preferred
  • Minimum of 5 years or related experience, including at least 3 years experience in US Regulatory Affairs (Clinical Regulatory Affairs)
  • Prior experience with drug IND/NDA/ANDA preferred
  • Prior experience interacting with the FDA
  • Experience developing pland for submitting INDs
  • Strong working knowledge of FDA guidance documents, CFR, GCPs, GMPs, and ICH

Responsibilities:

  • Provide regulatory support for ongoing and planned clinical trials including the review of essential regulatory document, protocols, SAP etc.
  • Plan, author and/or review documentation to ensure timely submission of product annual reports and related DMFs for assigned programs.
  • Support the development of regulatory strategies to provide internal guidance for business partners and management.
  • Provide authoring and/or review of technical and scientific documentation for inclusion in INDs, NDAs, ANDAs, amendments and supplements accordingly.
  • Evaluate new scientific literature, guidance documents, and regulations that may impact assigned projects or the company.
  • Liaise with internal colleagues, outside vendors/contractors and FDA and other government agencies regarding development product activities and/or submissions and amendments.
  • Prepare meeting/briefing package documents for FDA meetings and ensure management and pertinent team members are well prepared prior to FDA meetings.
  • Prepare draft responses and amendments to IND, NDA, and ANDA submission inquiries.
  • Attend meetings as the regulatory representative when required to support developmental or commercial activities.
  • Perform any other tasks/duties as assigned by management.

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