KIK Custom Products

Regulatory Affairs Specialist (Divisional)

Job Location US-IL-Rosemont
Posted Date 3 weeks ago(1/29/2018 12:18 PM)
Job ID
# of Openings


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The Regulatory Affairs Specialist brings simple and workable solutions by producing high-quality documents quickly and efficiently. The specialist is team player who is responsible for establishing and maintaining Canadian and US regulatory compliance for all of the KIK Custom Products, KCM division locations.

Essential Job Functions

  • Responsible for establishing and maintaining all Regulatory processes across KIK Custom Products Division. 
  • Responsible for regulatory impact analysis; especially regarding change controls and new products.
  • Manages regulation change impact analysis and implementation of changes as a result of those changes.
  • Supports new product filings.
  • Manages site registrations.
  • Assist with various projects as assigned.


  • Bachelor degree (or higher) in area of discipline.
  • Minimum 3+ years’ experience in Regulatory Affairs in a Pharmaceutical or OTC environment required; 5+ years’ experience preferred.
  • Knowledge of FDA and Health Canada regulatory history, guidelines, policies, standards, practices, requirements and precedents.
  • Knowledge of principles and requirements of applicable product laws including submission/registration types and requirements GxPs (GCPs, GLPs, GMPs); including principles and requirements of promotion, advertising and labeling.
  • Travel division sites is expected as necessary.

KIK is an Equal Opportunity / Affirmative Action Employer


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