Regulatory Specialist

Position Title : Regulatory Specialist.

Job Overview :

We are looking for a motivated, detail oriented, quality conscious Regulatory Specialist that will be responsible for managing and maintaining formula documentation, final product specifications, and regulatory registrations. This position requires high attention to detail as well as excellent organizational skills. The ideal candidate will be capable of working with minimal directions to assist departments with regulatory processes. The role will assist other departments, including product development. This position reports to the VP of Quality.

Key Responsibilities :

• Responsible for good documentation practices surveillance at the manufacturing facility along with the other QA / QC team members.
• Implement and continue to upkeep documentation per quality procedures.
• Support the VP, Quality in reviewing and approving US and International labels against the formulas to ensure accuracy.
• Review and approve formulas and final product specifications.
• Assist with change controls ensuring all documentation is updated.
• Review and approve Standard Operating Procedures (SOPS).
• Organize, file, and maintain controlled document files such as Certificates of Analysis and other cGMP logs / documents.
• Communicate with regulatory bodies to register products and schedule and assist with audits.
• Authority for acceptance / rejection of documentation based on their compliance with current specifications and government standards.
• Review Bill of Materials (BOMS) in Excel, Word and the electronic ERP system.
• Additional duties as needed.

Required Qualifications :

Physical Requirements :

Additional Details & Benefits :

Notice to Recruiters : We do not utilize outside recruiters. Please do not solicit.

The description of this role is not intended to be an exhaustive list of responsibilities and qualifications. The position, duties and qualifications are subject to change at any time.