Regulatory Manager

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;