Regulatory
NewRegulatory Affairs Specialist
Position Summary
The Regulatory Affairs Specialist will report to the Director of Regulatory Affairs, and will manage international regulatory matters pertaining to the registration and compliance of the company’s nutritional supplements, foods, and cosmetic products and will provide regulatory guidance to a number of in-house departments and personnel. This position will also collaborate with surrounding departments to ensure documentation compliance and contribute to process improvements. The Regulatory Affairs Specialist is expected to proactively follow through on assigned projects, showing a high level of organization and attention to detail. Other daily tasks may include gathering, filing, organizing, and ensuring accuracy of documentation of projects involving R&D, raw materials and finished product specifications and ensuring regulatory compliance for marketing materials for assigned markets regulations.
Essential Duties and Responsibilities include the following and other duties as assigned.
- Understand the regulatory landscape of the company’s markets and create strategies which will ensure that the planning and execution of each regulatory filing is managed effectively and efficiently, on schedule and within budget.
- Have basic understanding of advertising regulations in the company’s markets and help provide guidance to our marketing and sales team as needed
- Work directly with regulatory contacts in all markets, including company personnel, legal counsel, regulatory consultants and government agencies in order to register/notice the company’s products and comply with applicable regulations and laws.
- Work closely with Research and Development, Quality Assurance and Purchasing organizations to obtain the documents required to register/notice the company’s products, to include product testing, product safety, manufacturing processes, labelling and product claim substantiation.
- Ensure that marketing materials are compliant in relevant markets and maintain/manage documentation files.
- Have a working knowledge of relevant product laws and regulations.
- Dossier compilation in partnership with Regulatory, Ops, Quality, R&D
- Other duties as assigned
Education and/or Experience
- Bachelor’s degree preferred.
- Network marketing industry experience is a plus
- 6 months – 1 year of relative regulatory experience – this is an entry level position.
Qualifications/Skills
- Ability to understand and interpret documents related to specifications, quality and regulatory standards, etc.
- Strong mathematical and analytical skills
- Strong attention to detail
- Ability to prioritize and execute multiple tasks in a fast-paced environment
- Ability to communicate effectively and professionally, both orally and written
- Ability to work in a team-oriented, collaborative environment.
- Ability to be a self-starter
- Identifies opportunities for improvement and makes constructive suggestions for change
- Proficient computer skills