As a leading manufacturer of nutritional supplements and other health-building products, we are dedicated to enhancing the wellbeing of our customers - through research, development and delivery of effective nutritional products. It is our mission to contribute to the lives of our customers, employees, suppliers and the communities we serve, in a cooperative and sustainable manner.
The Opportunity:
Are you an expert in working with the FDA and other regulatory bodies to obtain licensing for nutritional supplements? Do you enjoy managing projects with a keen eye for details and timelines? Want to learn how your skills can help improve people's health while respecting the resources of our planet? If so, we have an exciting opportunity to join us as a Regulatory Affairs Manager! If this kind of work gets you excited, we would love to hear from you.
We are a growing company and a leading manufacturer of nutritional supplements, dedicated to enhancing the wellbeing of our customers.
In this role you will:
- Review formulations, ingredients, concepts and claims to help provide directions on regulatory compliance with FDA and other regulatory agencies
- Draft and submit licensing applications
- Maintain post-approval regulatory activities
- Support operational activities, such as label and marketing material reviews, in line with requirements of FDA and other regulatory agencies
- Lead and prepare §403(r)(6) structure/function claim submissions to the FDA Actively track status of on-going projects / documentation requests
- Liaise with external industry groups, trade associations, and partners to keep updated on any changing regulatory laws and trends.
You have:
- University degree or technical diploma in related scientific field
- Experience in regulatory affairs related to health supplements, food, or pharma
- Knowledge of DSHEA, CFR, cGMP, Prop65, and other regulatory guidelines
- Experience with international regulatory agencies is preferred
You want to:
- Work for a company that cares about its staff and has a meaningful mission to improve the lives and well-being of its customers.
- Be part of a company that is rapidly growing and where you can grow within the company.
- Challenge yourself by working in a fast-paced work environment
- Work in a facility where safety and cleanliness are highly regarded and a regulated work environment working to procedures, Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)
You get:
- A competitive salary
- Best in class benefits! Fantastic health insurance, generous time off for vacation and wellness, employee appreciation events, and discounts on company products.
- The opportunity to work with great people, the ability to influence and lead change within a company dedicated to continuous improvement.