Manager - Regulatory Affairs
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WAGE CATEGORY: Exempt
DEPARTMENT: Operations
LOCATION: Burlington, VT
REPORTS TO: Director of Quality
DATE/REVISION DATE: July 2008
OVERVIEW
The Manager - Regulatory Affairs is responsible for overseeing all activities associated with research, coordination, documentation and ongoing maintenance of the systems and processes required to manage compliance with regulations and other standards associated with products, packaging claims, and claims made on all other Seventh Generation materials.
PRIMARY RESPONSIBILITIES
- Manage the coordination of external resources and information related to compliance with all regulatory laws, rules, Guidelines and standards.
- Establish processes to support the continuous updating and maintaining of the knowledge base within the company with regard to regulatory and other standards related to Seventh Generation products.
- Ensure competent systems are in place to update and maintain current knowledge of FDA, EPA, REACH, international regulations, Kosher, Organic, guidance and any other standards applicable to Seventh Generation products.
- Develop implement and maintain the systems and processes necessary to ensure timely compilation of materials for license renewals, updates, registrations, and certifications.
- Oversee the successful collection, completion and filing of information and prepare appropriate regulatory documentation packages for submission to regulatory agencies or to Manufacturing Partners.
- Develop and maintain regulatory files/database and chronologies. Track changes. Maintain document archives.
- Liaison with appropriate resources to develop and maintain safety and toxicology profiles for products.
- Review labeling and labels for compliance with regulatory requirements and identify opportunities to expand the process to ensure claims accuracy.
- Manage the process of creating, and establishing detailed product specifications ensuring appropriate communication, filing and cataloging of specifications.
- Create and implement an effective sign off and communication process for the distribution of specifications and formulas by appropriate parties both inside and outside the company.
- Lead the facilitation and coordination of documentation and corresponding changes with all Manufacturing Partners, vendors and others where needed.
- Commit to personal development and professional growth by actively participating in personal development initiatives and applying developmental thinking within the context of planning and executing work.
KNOWLEDGE and SKILL REQUIREMENTS
Degree in, Quality, Business, Environmental Science, or equivalent combination of education and experience.
Strong organizational, verbal, and written skills with passionate attention to detail.
8 years experience overseeing regulatory compliance 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 Essence, Global Imperatives, Corporate Direction
and socially responsible practices
Strong project management skills
Team player with "can-do" attitude.
Willingness to continually embrace personal and professional development
WORKING CONDITIONS
Office environment
No specific physical requirements
Travel is expected up to 20% of the time
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Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
The job specifications cited in this Job Description are not to be interpreted to be a complete list of all the qualifications and performance expectations needed to perform this job adequately. Management can at its discretion add, drop or change at any time the duties, responsibilities and expectations of this job.
This job description does not constitute an offer of employment, continuous employment or an employment contract.
Qualified applicants should send a current resume and cover letter to staffing@seventhgeneration.com.
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