Regulatory Manager
Department: R&D
Location: Spring Hill, TN
The Regulatory Manager oversees the supervision of Regulatory Specialists, Quality Systems Specialists, Finished Product Coordinator and QA Documentation Control Specialist to ensure the product process requirements and regulations are met according to Customer, FDA and other applicable regulatory standards while maintaining employee safety.
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;
- Work with R&D and customers to create compliant labels;
- Proofread 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 regulatory agencies;
- Manage label revisions internally and develop a tracking process for label inventory;
- Manage 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;
- Maintain and monitor Quality System Programs (Non-Conformance, Internal Audit, training, etc.) to ensure 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- 5-10 years of progressive experience in Food Safety, Quality, and Regulatory Affairs.
- Experience in dietary supplements, contract manufacturing or food ingredient manufacturing strongly preferred.
- 3-5 years of leadership experience managing teams
- 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.
- Ability to stand and sit for extended hours;
- Ability to view a computer screen and type for extended hours;
- Work environment is normally in an office setting. Must be able to make frequent rounds in a warehouse environment;
- Other physical requirements include occasional squatting, bending, twisting, and bi-lateral hand and wrist movement;
- Ability to lift up to 25 lbs.;
- Ability to wear any required PPE;
- Ability to work around a variation of different smells and aromas;
- Ability to adjust work schedule as business needs require.
Benefits: - Medical, Dental, Vision
- Employer paid STD and LTD
- HSA and FSA
- Paid Maternity and Paternity Leave
- PTO
- Employer paid Basic Life Insurance
- 401(k) & Roth with employer match
- Eight Paid Holidays + 3 Floating Holidays
- Voluntary - Critical Illness, Hospital Indemnity, Accident
- Personal growth including training and development opportunities
