Regulatory Manager

Prinova•Spring Hill, TN

3d•Onsite

About The Position

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.

Requirements

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

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