May 24th, 2018

Regulatory Affairs Compliance Manager – Dietary Supplements in Orange County

Regulatory Affairs Compliance Manager for Dietary SupplmentsClient is seeking a Regulatory Affairs Compliance Manager to ensure regulatory compliance is implemented and followed at this high-volume contract manufacturer of dietary supplements. Client is in need of someone with manufacturing experience in FDA-regulated products such as pharmaceuticals, over the counter drugs, or dietary supplements.

Duties

  • 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