Regulatory Associate

Location: Buena, NJ

Job Summary:

The Regulatory Associate will assist the Director of Regulatory Affairs in the creation of regulatory submissions to the FDA.  Will maintain drug marketing licensure through the FDA (Annual Reports, PADERs, state licenses).  Will maintain site registration.  Will assist with labeling creation and review.  Will keep current in regulatory laws and processes.

Essential Responsibilities:

  • Interact effectively with functional business units in order to facilitate documentation requirements for submissions, ensuring departmental timelines are achieved. Communicate and coordinate regulatory activities with other departments.
  • Create, review and approve labeling
  • Monitor and collect all deliverables required for regulatory submissions.
  • Compile all materials in an orderly fashion to facilitate timely submission of materials to the FDA.
  • Review submission materials including labeling, sectional reports, data and final reports for errors prior to submission.
  • Maintain current regulatory knowledge of guidelines, regulations and standards and apply appropriate implementation strategies.
  • Assist in responding to FDA deficiency notices in order to bring new and existing filings into compliance with FDA guidelines.
  • Maintain files of drug products and all regulatory correspondence.
  • File, maintain and keep current all state and federal licenses and registrations.
  • Maintain site registration with FDA through SPL site.
  • Compile and submit Annual Reports and PADERs.
  • Other duties as assigned.

Qualifications:

  • Bachelor’s Degree in Chemistry, Biological Science, Regulatory, equivalent degree.
  • Minimum of two (2) years in the Pharmaceutical Industry in a Quality or Regulatory role.
  • Have an understanding of FDA regulatory submissions.
  • Excellent written and oral communication skills.
  • Excellent computer skills including Word, Excel, and Adobe.
  • Ability to work on multiple projects and meet timelines.
  • Strong reasoning, interpretive and decisive skills.
  • Results-oriented with the ability to balance multiple priorities and business considerations.

Physical Demands/Factors:

  • Physical Demands
    • Mobile/Ambulatory
    • Sight
  • Environmental
    • Move between buildings
    • Sit for long periods

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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