Regulatory Manager
Date Posted
8/29/23
Location
Spring Hill, TN
Position Id
2117
Degree Required
Job Type
Job Description
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;