Regulatory Affairs Manager

PURPOSE STATEMENT :

This position will be responsible for managing and coordinating implementation of regulatory requirements across all Blueroot Health brands, reflective of both the FDA CFR section 111 and the Company’s policies and practices.

This coordination includes making sure the Company is fully compliant and meeting all requirements for product registrations (dietary supplements, foods, medical foods and medical devices), product label reviews and approvals, confirmation of ingredient status (i.

e., GRAS, NDI) of raw materials used in products and product claims (Structure-Function, Health Claims, Nutrient Content)review in all customer-facing materials and content (labels, marketing collateral, websites, and presentations) along with managing scientific substantiation support and documentation for these claims.

Management, Adverse Events Reporting and appropriate regulatory Document Control is also the responsibility of this position, as are compliance execution for International Trade and International regulatory product filing coordination.

MAJOR RESPONSIBILITIES :

Oversight for coordination and execution of regulatory requirements (as defined under DSHE, NLEA, Medical Foods and Medical Devices) and procedures, ensuring full compliance across all brands of the Company.

Management coordination of regulatory review of product information including technical specification issues (cross-functional with Quality Assurance), marketing / sales literature, labeling requirements, and advertising materials.

As a member of a cross-functional review team, provide revisions to copy and claims that will be compliant and substantiated.

Oversee the customer inquiries by distributing questions and / or coordinating with other personnel for timely responses.

Monitor competitive claims, FDA’s and FTC’s actions, litigation, news releases, and other sources, as they relate to the current science of company-related products and challenges to prevent product claims, to ensure that the company limits its exposure for product claims.

Work with Quality Control Teams as defined under SOP requirements to help maintain label systems, create, and maintain product labels while working closely with the assigned cross-functional team responsible for label copy and reviews.

Work with marketing teams for label compliance and compliance reviews of all website content and all claims used in labels and collateral.

Ensure full compliance with FDA and FTC requirements for claims, supporting product and company content, copy provided by influencers and bloggers’ and all consumer facing materials and content and their substantiation support

Work with the Product Portfolio Team on all new product launches and relaunches to define and confirm regulatory compliance.

Assist and support in the process of customer and government regulated internal audits along with the requirements for NSF Certification audit and maintaining that designation for cGMP compliance.

As appropriate, suggest areas of improvement for system management and / or processes and make recommendations for changes.

Provide reports and other information as required for Management review of Quality / Regulatory Systems and / or NSF Certification to ensure full compliance as defined by the FDA, FTC and NSF cGMP requirements.

Ensure Quality Systems Management processes are in place across all brands and coordinated for consistency across all under the Blueroot Health System requirements.

Liaise internally with members of the company’s functional departments to ensure full compliance with Agency requirements across the Company.

KNOWLEDGE / SKILLS / EXPERIENCE :

Master’s degree in a scientific field is required with emphasis on regulatory affairs and in the dietary supplements category.

Experience in regulatory fields with oversite in Foods, Medical Foods, Medical Devices and OTC a plus.

Seven -plus years of experience in a regulatory role having oversite to compliance and involvement in QMS in the nutrition and dietary supplement categories.

Experience with NSF Certification requirements a plus.

Direct experience with ingredient line generation for dietary supplements and / or nutrition facts panels, and product labeling - claims requirements in the United States.

Some knowledge and experience of International and International Trade regulatory requirements would be helpful.

Ability to develop and review substantiate claims documentation (Structure function, Nutrient content, Dietary supplement, etc.

and effectively communicate regulatory stance on such claims to internal and external customers.

Knowledge and experience of California Prop 65 requirements.

Specific experience and knowledge of dietary supplements cGMP requirements.

Knowledge and experience of international regulatory requirements and submissions, including awareness of e-commerce requirements.

Knowledge and experience with adverse events reporting and investigation.

Experience in SOP Training for all teams of the company.

Formal certification for any specific regulatory compliance practice is a plus.