Senior Manager Regulatory Affairs

Position Summary:

Ensures appropriate review and development of product labels, claims and promotional sell copy for domestic and international dietary supplement, food and personal care products and performs final review and approval. This position is the Global Regulatory liaison for all product issues.

Position Scope:

• Reviews labels, formulas and product claims and sell copy for compliance with current FDA Food & Drug Administration), FTC (Federal Trade Commission), domestic state regulations as well as various international standards. Coordinates with Marketing, Purchasing, Quality, Customer Service and Operations.
• Manages the activities of the direct reports in ensuring that the day to day requirements of their department is being met and deadlines being achieved.

Position Responsibility:

• Responsible for the leadership and support of Regulatory Affairs department including project management and delegation of tasks. Ensures appropriate review of all CL products labeling, nutrition information, ingredient statements, nutrient claims and marketing information in accordance with internal procedures. Ensures internal regulatory labeling procedure is current and is sufficient for CL requirements.
• Works with internal departments, including Research & Development, Marketing, Purchasing, Manufacturing and Packaging on new launches to resolve issues and ensure timeliness of new product introduction.
• Ensures international product label regulatory compliance. Reviews and implements label changes due to international product registrations and international distributor requests. Oversees international regulatory submissions.
• Develops and trains personnel in FDA and FTC regulations.
• Develops and maintains regulatory knowledge as regulatory environment evolves. This includes, but is not limited to, monitoring of government websites (FTC, FDA), literature searches, and regulation research.
• Participates internally with teams with regard to implementation of regulatory requirements, e.g. participates with the Marketing Team for new or modified products as regulatory liaison for product issues. Evaluates regulatory implications and justifications for all label creation / revision. Works with Marketing to develop layout consistent with regulatory standards.
• Ensures that customer complaints are investigated, resolved and that the resolution is documented. This may include knowledge of the complaint investigation process, interaction with distributors and customers for resolution of issues.
• Solid understanding and ownership of the necessary certifications that the company chooses to attain including but not limited to NGPV, GFCO, Halal, Kosher, NSF, UL, Butterfly, B Corp, and others that the company chooses to attain.
• Participate in various audits. Prepares and presents the required information for the auditors.
• Reviews and works with company legal representation to respond to legal documents presented to the Company.
• Reviews and delegates as needed all marketing claims, advertisements, promotional material as well as all product training documents prepared to ensure compliance.
• Human Resource functions to include managing Total Reward Program as appropriate for their department, subordinate performance reviews, recommending promotions, issuing disciplinary warnings.
• Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.
• Satisfactory completion of appropriate corporate training as related to the position and/or department.
• Assures compliance by following Food and Drug Administration's Good Manufacturing Practices (FDA cGMPs), ALERT as well as other regulatory standards as required by the organization.
• Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.
• The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

QUALIFICATIONS

Experience and skills:

• 5+ years experience in the field of international and domestic Regulatory Affairs, preferably in the Dietary Supplement, Food and Cosmetic industries.
• 3 years of managerial experience.
• Knowledge of MS Office, Word, Excel, PowerPoint, Quark
• Detail-oriented, accountable, adaptable, assertive, motivating, collaborative, and forward thinking.
• Ability to work independently and work as a team leader to coach and develop associates.
• Excellent communication and organizational skills.
• Must be able to interface with professionals domestically and internationally.

Education and certifications:

• B.S. in Science, Nutrition, or other related field is required.
• Master’s degree in Nutrition, Regulatory or other science based field is a plus.
• International and/or Personal Care regulatory experience is a plus.