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Years of Experience
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ProfileRegulatory Affairs Labeling Claims Manager Responsibilities: Responsible for the proper development, substantiation and maintenance of claims, across all brands and platforms, domestically and internationally, in order to effectively ensure compliance with applicable laws and regulations and minimize risk as it relates to potential litigation. Responsible for managing and developing a team of direct reports. Manages direct reports including goals setting, performance evaluation, coaching and talent development. Ensures that new product development, claims substantiation and digital projects are achieved, per agreed upon timelines. Coordinates and collaborates with Innovation, Marketing (Domestic & International) and Scientific Affairs in order to develop compliant, science based claims. Works with Scientific Affairs (SA), ensures that all claims are substantiated, both upon creation and when revised, and that proper documentation relating to such substantiation is created and properly maintained Establishes, in conjunction with SA, a regular claims substantiation review to ensure that new science is captured and considered with respect to claims and such review is properly documented. Domestically, ensures active ingredients linked to claims are acceptable for use against relevant documentations such as but not limited to, Generally Recognized as Safe (GRAS) determinations and New Dietary Ingredient Notifications. Supports GRAS and FDA New Dietary Ingredient (filings) filings as required. Works with external counsel and subject matter experts on vetting claims substantiations. Ensures the consistent use of claims across all marketing avenues (i.e. label copy, web content, marketing collateral etc.). Reviews and approves new digital content, which includes NatureMade.com, retailer sites, social media and applications. Responsible for the maintenance of digital content by ensuring claims and other related information is up-to-date. Creates and manages the regulatory claims files, allowing other cross functional groups easier access to approved claims. Manages the submission of and tracks FDA 403(r)(6) 30-day notices for structure/function claims. Manages approval of label changes, as they relate to claims. Manages marketing material reviews and provides approval based upon established claims. Monitors U.S. competitive claims, FTC's actions, NAD actions, litigation, news releases and other sources, as it relates to the current science of VMS products and attacks or potential attacks on VMS product claims; ensure that has acceptable exposure from a claim's perspective. Provides guidance to and partners with Innovation, Marketing and Sales on product concepts, claims and formulations in order to ensure compliance with applicable legal and regulatory requirements, including without limitation in the case of domestic products FDA and FTC requirements. Monitors the development and assesses the impact of new and proposed changes in laws, rulings, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising. Participates in appropriate scientific and trade associations as assigned. Assists in identifying and addressing potential patent and trademark issues in conjunction with in-house legal counsel. Assists Legal in researching and responding to issues related to litigation and other legal matters, as needed. Performs other related duties as assigned.
Qualification and Experience
Qualifications: Requires a bachelor's degree in a scientific field in Chemistry, Biology, Nutrition/Food Science, Regulatory Science, or related field. Master's degree or JD Degree preferred. Regulatory Affairs Certification (RAC) is preferred. 4-5 years' experience in U.S. dietary supplement regulatory affairs with in-depth knowledge of FDA and FTC regulations, as it relates to claims. Managerial experience required. Knowledge/Skills/Abilities: Requires: Managerial and leadership competence to coach, motivate and develop staff. Comprehensive and working knowledge of laws and regulations pertaining to the manufacture and marketing of dietary supplements. Competent knowledge of nutrition and health sciences. Strong problem solving, analytical and strategic thinker with good business acumen. Strong oral and written communication skills, including public presentation and facilitation of team meetings. Good project management capabilities. Ability to engage and influence cross functional team. Working knowledge of MS Project, preferred. Strong organizational skills with ability to multi-task well. Self-starter as well as strong team player. Ability to collaborate with internal and external customers to ensure good customer service Ability to lead, develop, mentor and oversee staff. A "big picture" perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity.