Regulatory Affairs Specialist III
Manages domestic and/or international regulatory matters pertaining to the registration and compliance of the company’s nutritional supplements, foods, and cosmetic products. Provides regulatory guidance to a number of in-house departments and personnel. A subject matter expert in the regulatory landscape of the company’s foreign and domestic markets.
A publicly-traded nutritional supplement company, located in Lehi, Utah, is seeking an experienced Regulatory Affairs professional with at least 5 years of experience to assist the company in its domestic and international expansion efforts.
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.
- 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.
- Coordinate with Project Managers regarding regulatory timelines and risks.
- Have a working knowledge of relevant product laws and regulations.
Education / Experience
- Bachelor’s degree preferred
- 5+ years’ applicable experience and/or training.
- Comprehensive knowledge of laws and regulations applicable in an FDA- and FTC-regulated environment.
- Familiarity with the food, dietary supplement, and cosmetic categories.
- Project management capability.
- Strong oral and written communication skills.
- Ability to respond to inquiries from regulatory agencies, customers and business community.
- Ability to organize large amounts of information with attention to detail.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.