Regulatory Affairs Specialist – Onsite – Ottawa, Illinois

The Regulatory Affairs Specialist will ensure global compliance with all cosmetic and OTC regulatory requirements by performing a wide range of tasks. This role involves supporting and selectively managing regulatory affairs matters, collaborating with supervisors and key business partners to support global regulatory programs and strategies. Responsibilities include supporting new and existing products, process improvements, product registrations, and global market compliance. The specialist is responsible for implementing protocols, processes, and programs to maintain robust and compliant regulatory practices companywide.

Responsibilities:

• Collaborates with cross-functional project teams to complete regulatory-related assignments (such as Ingredient Lists, Quantitative Formulas, CCS) for both new and existing products, and clearly communicates requirements to colleagues.
  

• Ensures documentation related to regulatory matters, process and product/label changes are accurate and compliant.
  

• Works with supervisor to develop and communicate regulatory compliance requirements in support of New Product Development.
  

• Maintains regulatory files including claims support packages for new and existing products to ensure compliance and support/defend legal inquiries/challenges and regulatory audits.
  

• Works with supervisor to provide regulatory guidance with respect to short and long-term business planning.
  

• Monitors, interprets, makes recommendations to update product compositions, company procedures and documents with respect to forthcoming and/or changing state, US, and global regulatory requirements.
  

• Provides regulatory guidance/training as needed, ensuring compliance with all regulatory requirements in existing and new markets.
  

• Keeps Research and Development team updated of changing regulations and developing formulation guidelines.

Experience:

• Bachelor Degree and 2+ years in equivalent Regulatory Compliance Industry Experience (additional experience can substitute for degree requirements)
  

• Strong knowledge of cGMPs
  

• Hands-on experience with FDA regulations, Health Canada Regulation, EU regulations and guidelines.
  

• Hands-on, working knowledge of FDA OTC and cosmetic product regulations
  

• Experienced with label and claims review process
  

• Knowledge related to state based regulatory bodies and requirements (ex: Prop 65)
  

• Excellent oral and written skills
  

• Experience writing SDSs
  

• Open, honest communication skills
  

• Statistical Evaluation of data
  

• Understanding NGO requirements such as the Non-GMO project.
  

• Strong computer skills utilizing a Microsoft environment (Word, Excel, Access, Power Point)
  

• Reasoning Ability:
  

  • Has the ability to define problems, collect data, establish facts, and draw valid conclusions in any situation
    

  • Has the ability to solve problems and deal with a variety of variables in situations where only limited information exists.
    

Details:

• Direct Hire
  

• $70,000 – $90,000/year with Benefits
  

• Onsite in Ottawa, IL – relocation assistance negotiable

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