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Sr Manager, Regulatory Affairs & Compliance (Nutraceuticals)

Company: Keystone & Golden, Inc.
Location: Middletown
Posted on: September 21, 2022

Job Description:

Our Client is an industry leading distributor of nutritional supplements offered in both the DTC and Practitioner Channels. The Company has recently acquired four brands and has a unique growth strategy focused on condition specific health solutions and a commitment to consumer centric needs. The products are category leaders in specific channels and experiencing significant growth over the last several years. By providing comprehensive support through their line of over 300 products, ongoing clinical education, and practice development programs, they help maximize the potential for successful health outcomes.

This is a fully remote position

Summary:

This individual will be responsible for managing and coordinating implementation of all regulatory and quality management systems requirements across all 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 and medical devices), product label reviews and approvals, confirmation of ingredient status (i.e., GRAS, NDI) of raw materials used in products claims review in all customer facing materials and content (labels, marketing collateral, websites and presentations) along with managing substantiation support and documentation for these claims. Management of cGMP Quality systems (i.e., SOP's, SOP Training, Adverse Events Reporting, Document Control) for full integration across all Brands is a critical responsibility of the position Coordination of the regulatory review process and cGMP standards across a multi-disciplinary team is an integral role to maintain regulatory compliance and a demonstration of the Company's full commitment to users of the company product portfolio.

Essential Functions:

  • Oversight for coordination and execution of regulatory requirements and procedures, ensuring full compliance across all brands of the Company
  • Management coordination of regulatory review of product information including technical specification issues, marketing/sales literature, labeling and advertising materials. As a member of a cross functional review team, provide revisions to copy and claims that will be compliant.
  • Oversee the customer inquiries by distributing questions and/or coordinating with other personnel for timely responses to customer inquiries
  • Monitors 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 company limits its exposure for product claims
  • Assist in the evaluation and monitoring of domestic contract manufacturers
  • Work with Quality Control Teams as defined under SOP requirements to help maintain label systems, create and maintain product labels while working closely the assigned cross-functional team responsible for label copy and reviews.
  • Work with marketing teams in for label compliance and compliance reviews of all website content.
  • Work with the Product Portfolio Team on all new product launches and relaunches to ensure full 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 and NSF cGMP requirements.
  • Ensure Quality Systems Management processes are in place across all brands and coordinated for consistency across all under the System requirements
  • Liaise internally with members of the company's functional departments
    Education/Experience:
    • Master's degree in a scientific field is required with emphasis on regulatory affairs and Quality Assurance cGMP requirements in the dietary supplements category a plus.
    • Direct experience with regulatory compliance requirements for foods,dietary supplement and or medical device products..
    • Five to seven years of experience in a regulatory role having oversite to compliance and involvement in QMS. 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 Canadian 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 eCommerce requirements.
    • Knowledge and experience with adverse events reporting and investigations
    • Experience in SOP Training for all teams of the company.
      Formal certification for any specific regulatory compliance practice is a plus.

      Benefits include medical insurance, company-funded Health Reimbursement Account, 401K plan with company-match and a generous yearly allowance for company products for personal use (1000/year and 300 wellness stipend)

Keywords: Keystone & Golden, Inc., Middletown , Sr Manager, Regulatory Affairs & Compliance (Nutraceuticals), Executive , Middletown, Connecticut

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