The Regulatory Manager in Marketing Review Services (MRS) is responsible for project ownership, clients’ support, as directed in areas of regulatory compliance: Supplement Facts Review, Label Review, Claim Development, Claim Substantiation, Formulation Review, Marketing Acceptance, Confirmatory Label Review, Website Review, Ingredient Review. Create and Peer Review draft reports and marketing copies. Design and develop controlled documentation. Organize regulatory information, track and control documentation, proof-read and provide input on compliance works in accordance with daily operating practices and the regulations, as cited under the applicable industry regulations relevant to the assigned projects.
- Write, review, collect, and coordinate assigned projects. Prepare regulatory documentation for submission, including label or copy reviews, website reviews, claim development, claim substantiation, formula reviews, and other associated data as directed.
- Lead and/or support the review of formulas, labeling practices and labels for compliance with regulatory requirements (e.g., structure-function claims and other allowable claims categories).
- Assess claims for allowance and compliance, providing corrective language where/when feasible, based on sound regulatory experience, interpretations and training.
- Research claim substantiations for the preparation of documents to support product label and advertising claims.
- Review technical data to ensure accuracy on all supplement and nutritional fact panels.
- Ensures clients’ product packaging are in compliance with U.S. labeling regulations.
- Provide information regarding current and emerging food labeling issues and opportunities, and its impact on products and product technology.
- Maintain current knowledge of FDA, FTC, USDA labeling and marketing material guidance and standards applicable to clients’ products.
- Actively participate in evaluation of regulatory changes affecting compliance of documentation, product(s), process(es) and methodologies.
- Provide team and client leadership with guidance on compliance matters and regulatory operations with respect to known strategies and activities.
- Participate in research of regulatory issues and disseminate information to team members for in-person, teleconference and other communications with client or partners as required.
- Establish and maintain project management system for tracking changes in documents and maintain regulatory files/database on assigned projects.
- Operate seamlessly within team in a project management-driven environment to keep all projects updated/current, reporting of billable time, and proper utilization of company software and resources to ensure traceability and accountability.
- Participate as needed in tradeshows, conferences and other industry-related events.
- BS in a scientific field is required. MS, Ph.D. (preferred).
- Ideally minimum of 10 to 15 years’ experience in Regulatory Affairs within the Food & Beverage, Dietary Supplement, Cosmetic and/or Homeopathic industries.
- Extensive knowledge in FDA, FTC, USDA regulations. Knowledge of FDA CFR 21 101 highly desired.
- Experience with developing regulatory strategy for dietary supplements, foods, and cosmetics, including claims, labeling, and claim substantiation, formulation reviews and certifications.
- Knowledge of NFP and SF RDI and %DV calculations.
- Must be able to handle multiple projects.
- Proficient in MS Team, Word, Excel and Adobe.
Total Target Compensation: Based on qualifications, experience, and interview performance. Performance based role (base salary with quarterly/annual bonuses based on billing targets)
100% Paid Benefits for Employees:
– Medical Insurance (Gold/Platinum Plans for 2 HMO and 1 PPO options)
– Vision Insurance
– Dental Insurance
Other Benefits available:
– 401(k) Safe Harbor 100% vesting
– Dedicated HR through PEO with Online Employee Portal for all payroll and administrative needs
– 13 Company Paid Holidays per year on top of allocated Paid Time Off (PTO) Days
– Several other life benefit services and insurance options available e.g. Financial Planning, Counseling Services, etc.
If you are interested in applying for this position, please email your resume to: email@example.com