Client is seeking a Regulatory Affairs Compliance Manager to ensure regulatory compliance is implemented and followed at this high-volume contract manufacturer.
Manufacturing experience should include FDA-regulated products such as pharmaceuticals, over the counter drugs, or dietary supplements.
• Manage coordinate and prioritize the daily activity of the department and related staff
• Interact with various departments as needed on regulatory compliance issues
• Direct, plan, delegate and manage departmental budget and staff
• Manage, maintain and support effective implementation of Regulatory Affairs
• Ensure compliance relating to product, labeling registration and licensing
• Oversee, conduct, and review investigations relating to customer complaints, deviations, and product variances, or failure investigations
• Oversee and ensure SOPs and company policies are in compliance with regulatory requirements and GMPs
• Provide support in both internal and external audits to ensure regulatory compliance
• Obtain licenses and certifications from State and Federal agencies, third party Certification bodies, other customer third party inspections and foreign registrations
• Oversee and schedule internal audit and take lead in the resolution of non-compliance