Regulatory

  • location: Saint Paul, MN
  • type: Contract
  • salary: $30 - $35 per hour

job description

Regulatory

Job Title: Regulatory Affairs Associate III

Position Description

  • Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions.
  • Review and evaluate technical and scientific data and reports required for submission in support of companies products.
Position Responsibilities

  • The incumbent will perform other duties assigned. Track of status and progress of regulatory documentation Review, edit and proofread regulatory documentation
  • Assist in preparation and review of labeling, SOPs, and other departmental documents
  • Compile under supervision regulatory documents for submission
  • Participate as an active team member of project teams as required, Compile and prepare responses to regulatory authorities questions
  • Maintain regulatory files in a format consistent with requirements
  • Maintain awareness of regulatory requirements
  • May be responsible for a specific product portfolio in the region
Position Requirements

  • Bachelors degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment.
  • Scientific knowledge
  • Written and verbal communication skills
  • Knowledge of regulations Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
  • Proofreading and editing skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Ability to multitask and prioritize
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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