Regulatory Specialist

Prairie Holdings•Worthington, MN
•$0 - $45,000•Onsite

About The Position

Ensure compliance via the coordination, preparation and review of regulatory documents, processes, and submissions to support animal health company.

Requirements

  • Ability to read and interpret documents such as regulatory guidance documents and procedures.
  • Ability to write routine correspondence.
  • Ability to apply concepts of basic math.
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
  • Ability to deal with problems involving variables in standardized situations.
  • Attention to detail.
  • Communication skills - verbal and written.
  • Data collection, management and analysis.
  • Problem analysis and problem solving.
  • Planning and Organizing.
  • Judgement.
  • Decision-making.
  • Customer service orientation.
  • Teamwork.

Nice To Haves

  • Minimum of a two-year degree in animal sciences, business, administration, or related field preferred
  • A minimum of one (1) year experience in compliance, customer service, administrative assistance, business administration, or related field preferred

Responsibilities

  • Review biologics orders for compliance and accuracy
  • Initiation, collection, and coordination of information of regulatory documents for various purposes
  • Coordinate and review regulatory paperwork
  • Resolve regulatory issues and facilitate opportunities for improvement by problem solving and collaboration with colleagues
  • Create and maintain databases of required regulatory information for tracking compliance
  • Assist in internal audits records, including but not limited to licensed documents, distribution records, and production records
  • Other duties as assigned
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