Regulatory & Scientific Affairs Manager
5 days ago
Hauppauge
Position Summary: The Regulatory & Scientific Affairs Manager ensures regulatory compliance for a portfolio of dietary supplement, food, and cosmetic products in the U.S. and international markets. Operating with a high degree of autonomy, the Regulatory & Scientific Affairs Manager provides end-to-end regulatory support for our products, including ingredient and formula review, claims substantiation, labeling, advertising collateral review, maintenance of third-party product certifications, and related tasks. Position Scope: • Manages activities within the Regulatory Affairs department, • Responsible and accountable for ongoing regulatory compliance of products, management of third-party certifications, and content management (label content and advertising/marketing collateral assets), • Reviews scientific literature and develops claims substantiation tables that summarize the evidence that supports each of our product claims Position Responsibility: • Under the direction of leadership and with a high degree of autonomy, the Regulatory & Scientific Affairs Manager is responsible and accountable for the ongoing compliance of our products, including but not limited to:, • Creating and maintaining label content, including Supplement Facts panels and all mandatory label information, • Reviewing label artwork for accuracy, completeness, and compliance, • Collaborating cross-functionally and with third-party certification bodies to obtain and maintain product certifications (such as GFCO, AVA, iGen, Kosher, Halal, Leaping Bunny and others as needed), • Reviewing and analyzing raw material documentation for completeness and to determine regulatory status (such as dietary ingredient, GRAS, food additive), substantiate product attributes (such as vegan status or nutrient content claims), and determine appropriate labeling, • Completing U.S. and international product registrations as applicable, including FDA Structure Function Claims Notifications or MOCRA registrations in the U.S., • Developing claims substantiation tables that include detailed citations and assessments of the quality of the evidence available to support each claim, • Maintains a high degree of technical knowledge of regulatory requirements, including but not limited to FDA, FTC, and USDA regulations and guidance, industry best practices, and enforcement trends, • Provides regulatory intelligence via horizon scanning and monitoring the development and potential impact of new, proposed, or emerging changes in laws, regulations and enforcement activities affecting our products and markets. Communicates such changes internally and leads efforts to ensure continued compliance without business disruption., • Proposes innovative regulatory strategies and acceptable alternatives or solutions when faced with a regulatory challenge., • Provides guidance and support to cross-functional partners (Marketing, Sales, Supply Chain, Manufacturing, R&D and Quality) that helps shape compliant product concepts, claims, and formulations., • Reviews, evaluates, and interprets scientific literature and other data as applicable to compile adequate substantiation for proposed product claims. Maintains professional and technical knowledge by attending educational symposia, reviewing publications, participating in trade associations and professional societies, and establishing a professional network., • Responsible for following Standard Operating Procedures (SOPs), company policies, and completing corporate training as applicable, • 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: • Bachelor’s degree required, preferably in a relevant field of study such as nutrition, chemistry, biology or political science. An advanced degree is a scientific discipline is highly desirable., • Requires at least five years of professional experience with an emphasis on regulatory affairs, preferably within the dietary supplement (VMHS) and cosmetic (personal and oral care) categories. Candidates with direct experience in international regulatory affairs (including formula compliance review, labeling, and/or product registration) are highly desirable., • Comprehensive knowledge of laws and regulations pertaining to the manufacture and marketing of dietary supplement and cosmetic products; A working knowledge of nutrition and health sciences, • Excellent communication skills and the ability to work with all levels of the company. Must be able to interface with professionals domestically and internationally., • Ability to work, collaborate and lead meetings with multiple stakeholders in a cross-functional team setting. Must be able to represent Regulatory Affairs interests effectively in an interactive team environment., • Strong organization skills, including project management capabilities and the ability to multi-task when necessary, • Knowledge of MS Office suite (Outlook, Teams, SharePoint, Word, Excel, PowerPoint), • Proven experience leading, developing, and/or mentoring a staff is a plus