Regulatory Affairs Ops Specialist III

Round Lake, IllinoisRandstad LifeSciences

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Job Title:  Regulatory Affairs Ops Specialist III (Serialization SME)

Position Description

  • Provide global regulatory strategy and support for serialization/track and trace initiatives for therapeutic product labeling. Support global registrations and ongoing compliance as it relates to serialization/track and trace throughout the supply chain and life cycle of therapeutic products.
  • Drive and execute global labeling strategies and plans for complex projects including new products and ongoing compliance for products already on the market. Understand and incorporate key labeling requirements and best practices into global labeling strategies.

Position Responsibilities

  • Help formulate and drive global serialization initiatives as well as global labeling traceability requirements within project and product teams.
  • Provide ongoing support and global oversight to ongoing global serialization and traceability programs,
  • Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.
  • Monitor applicable global regulatory and labeling requirements; assure compliance with company and external standards and help drive implementation across functions and projects.
  • Effectively assess impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
  • Effectively perform gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications.
  • Establish appropriate cross-functional partnerships within RA and other functions to drive key global labeling strategies and initiatives.
  • Ensure project teams and business objectives and deliverables are aligned with regulatory strategy

Position Requirements

  • HS Diploma or GED required
  • Bachelors degree strongly preferred


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance




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