Regulatory Manager


Spring Hill, TN


Main Duties & Responsibilities

  • Ensure compliance with established regulations and customer requirements, including GMPs as listed in 21 CFR 111 and 117, and Global Food Safety Initiative (GFSI) scheme.
  • Manage team of Regulatory specialists and their specialized functions, workloads, etc.
  • Work with R&D and customers to create compliant labels;
  • Proof read and review label content (includes building and inbound review process;)
  • Oversee the creation of manufacturing documentation;
  • Work with regulatory agencies to gather documentation and regulatory certificates;
  • Set up internal procedures to certify products with new regulatory agencies;
  • Maintain and/or improve current procedures to certify products with regulatory agencies;
  • Manage label revisions internally and develop a tracking process for label inventory;
  • Manage the implementation of manufacturing documentation revisions, including change control and deviations;
  • Complete final review and approval of product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products;
  • Support internal audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs are followed;
  • Assist in Quality System Programs (Non-Conformance, Internal Audit, training, etc.) to insure food safety and quality requirements are met;
  • Interface with outside governmental agencies, such as: USDA, FDA, TDA, etc., 3rd party auditors such as: BRC, QAI, OU, etc., and to consumers and customers through investigation and response to complaints;
  • Interface with customers for their audit requirements of our production facilities;
  • Monitor and maintain the Supplier Qualification Program;
  • Ensure products are compliant based on final delivery form and region of distribution;
  • Write regulatory processes and work with Quality Management to develop new quality processes;
  • Follow cGMP guidelines and processes as established in department SOPs;
  • Meet goals and objectives as outlined by the Executive Management team;
  • Perform other duties as deemed necessary.

Requirements and Skills

  • Bachelor of Science in related discipline required;
  • 2+ years of supplements experience in a related field;
  • Demonstrated leadership and team management skills;
  • Experience in motivating teams and team building;
  • Willing to work closely with a team and develop processes and team members;
  • Knowledge of label compliance requirements;
  • Experience working at a cGMP facility, experience working with NSF preferable;
  • Experience working with outside regulatory agencies;
  • Writing and/or technical writing skills, experience writing SOPs;
  • Detail oriented and highly organized;
  • Excellent written and oral communication skills;
  • Working knowledge of ERP Systems, LIMS, Microsoft office and general computer concepts;
  • Intermediate math, communication, and problem solving skills;
  • Strong documentation practices and record keeping skills;
  • Ability to follow company processes and procedures;
  • Ability to work without direct supervision;
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