Manager Regulatory Affairs

Manager Regulatory Affairs is needed for busy manufacturer located in the Morris County, NJ area. The Director will review and update the company’s SOP’s with other departments in order to keep the procedures up to date based on the FDA regulations. As a team member of the Regulatory & Compliance Department, you will be the lead contact for Government, third party and customer audits.

Additional responsibilities:

• Yearly registrations – FDA, NJ License/Permit, Health Canada, FSRN etc.
• OTC Product Registrations NDC’s
• Annual OTC reporting
• Accelerated Drug Stability submissions, review and reporting monthly results to customers
• Review and approve all protocols and reports for validations, IQOQ’s
• Review and approve all Deviations and Change Controls for all departments (review and approve all Master Batch Records against the R&D formula or customer transfers and all changes)
• Oversee the employee SOP training program and conduct training
• Review and approve Annual Product reviews
• Participate in line trials, OTC validations and new launches
• Participate in weekly meetings with customers

The Manager Regulatory Affairs must have a solid background in regulatory and compliance. SOP, FDA, and personal care / cosmetics experience. Team leader with great attention to detail skills.

To discuss in greater detail, please send resume outlining your regulatory and compliance experience.