The Regulatory Affairs Specialist is responsible for the research, coordination, documentation and ongoing maintenance of the systems and processes required to manage compliance with the regulations and other standards associated with personal care products, packaging claims, and claims made on all other Seventh Generation materials.
KNOWLEDGE AND SKILL REQUIREMENTS
- Coordinate and manage the external resources and information related to compliance with regulatory and other standards.
- Continuously update the knowledge base within the company with regard to regulatory and other standards related to Seventh Generation products.
- Maintain current knowledge of FDA, EPA, OTC, Cosmetic, Kosher, Organic, and FSC guidance and any other standards applicable to Seventh Generation products. Write and manage applicable business SOP’s to ensure compliance with standards.
- Develop the systems necessary to ensure timely compilation of materials for license renewals, updates, registrations, and certifications.
- Collect and coordinate information and prepare appropriate regulatory documentation packages for submission to regulatory agencies or to Manufacturing Partners.
- Maintain regulatory files/database and chronologies. Track changes. Maintain document archives.
- Work with appropriate resources to develop safety and toxicology profiles for products.
- Review labeling and labels for compliance with regulatory requirements.
- Support systems work necessary for specification development.
- Develop and maintain MSDS for personal care product lines.
- Work with R&D to secure and maintain raw material and packaging data and documentation.
- Support mock recall process on an annual basis
- Act as a backup for the International Regulatory Affairs Manager.
- Degree in Business, Environmental Science, or equal experience.
- Strong organizational, verbal, and written skills with passionate attention to detail.
- 5 – 10 years experience in regulatory discipline preferably in consumer packaged goods.
- Mature individual with capacity for rapid change and degree of ambiguity.
- Self motivated individual with the ability to work independently.
- Ability to coordinate the needs of multiple functional areas simultaneously.
- Ability to prioritize and meet deadlines within specified time constraints.
- Desire to work in small, entrepreneurial environment and for a socially responsible business.
- Strong computer skills, including Word, Excel, PowerPoint and Project.
- Knowledge of database analysis programs.
- Must exhibit a passion for the company’s Mission, Vision, Corporate Direction and socially responsible practices.
- Strong project management skills.
- Team player with “can do” attitude.
- Willingness to continually embrace personal and professional development.
No specific physical requirements
Some travel may be necessary
Seventh Generation - 12 months ago
Seventh Generation is the nation's leading brand of household and personal care products that help protect human health and the environment....