Regulatory Affairs Manager
As a Regulatory Affairs Manager within our fast-growing personal care and beauty company, you will be responsible for product files validation (list of ingredients, compliance with our Never List, Restricted LIST, ETC.), product and ingredient compliance advisement, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings, and research and monitor regulatory issues and provide guidance and advice to colleagues.
Specific Duties and Responsibilities:
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to partners, advise on the submission strategy
- Review regulatory and safety labeling and claims for compliance with regulatory requirements, working with various internal groups
- Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Provide the regulatory reviews of customer concerns and define the internal communication process
- Responsible for timely registration of the products
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
- Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC, Legal, and R&D departments and senior management as required.
Core Job Responsibilities:
- Represent Regulatory Affairs on cross functional and R&D product development project teams to ensure all Federal and State regulatory requirements are met throughout the development process.
- Complete submissions to FDA, Canada regulatory entities
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
- Supervise Regulatory Affairs consultants as required
- Monitor global regulatory issues/concerns
- Other duties as assigned
- Requires BS, MS, or PhD degree in a science or related field
- 10+ years relevant experience within the regulatory affairs discipline
- Knowledge of US and Canadian Beauty regulatory requirements
- International experience is a plus
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Founder and CEO
The Beautycounter brand is a force for change. Through both education and our unique direct retail model, we're more than a beauty brand. We're a movement.
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