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Manager, Regulatory Submissions

Title: Manager, Regulatory Submissions

Contract Length: 6-12 Months (potential temp-to-perm)

Location: New Jersey

The Manager, Regulatory Submissions will be responsible for the submission of information to HA's in support of the company's products. You will interact with Regulatory Authorities, as well as clients, to support various activities. You will be responsible for interacting with other teams as well as clients; providing strategy regarding HA requirements and project time-lines.

Responsibilities:

  • Prepare submissions filled to health authorities such as INDs, CTAs, NDAs, NDSs, MAAs and/or CTDs.
  • Prepare Quality OVerall Summaries for Phase 2 and Phase 3 Canadian CTAs
  • Serve as a Regional Lead for various studies to support clients with regional specific regulatory requirements
  • Compile INDs, IND Amendments, Meeting Requests and Meeting Packages for pre-IND meetings
  • Compile and submit Canadian CTAs
  • Coordinate with external clients and internal departments required for documentation to meet submission deadlines.
  • Lead the preparation of submissions by reviewing/summarizing scientific sections/research documents.
  • Coordinate, collect and organize information required.
  • Interact with the publishing group regularly.
  • Utilize knowledge and awareness of regulations/guidelines pertaining to drugs and biologics.
  • Monitor compliance with requirements in relation to assigned projects.

Requirements:

  • B.S., in Life Sciences or equivalent
  • Experience in the pharmaceutical industry - specifically within Regulatory Affairs
  • Experience compiling INDs and summarizing documents
  • 2-3 years+ of Regulatory Submissions experience

Sthree US is acting as an Employment Business in relation to this vacancy.