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Regulatory Affairs Specialist
2 months ago
Job Title: Regulatory Affairs Specialist
Location: Ottawa, Illinois (relocation assistance provided)
Salary: $70-90,000 + Benefits
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:
- 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)
- Experience writing SDSs
- Statistical Evaluation of data
- Understanding NGO requirements such as the Non-GMO project.
