A company is looking for a Senior Manager, Regulatory Operations.
Key Responsibilities:
Oversee and manage all regulatory submissions and compliance
Manage external publishing staff and ensure adherence to internal standards for submissions
Lead regulatory project management activities, including submission planning and tracking
Required Qualifications:
Bachelor?s degree with 8+ years of experience in Regulatory Operations or 10 years of related experience in lieu of a degree
Experience managing multiple active applications and ex-US regulatory submission processes
Advanced user of Microsoft suite and Smartsheets
Experience with Veeva RIM systems and SharePoint is a plus
Familiarity with computer system validation for FDA/EMA regulated systems is a plus
