Regulatory Manager
October 2
Description
• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents for submission to Regulatory Authorities • Serves as representative of Global Regulatory Affairs at project team meetings • Works within a project team and may lead project for the region or globally • Oversees and coordinates Regulatory Affairs Specialists • Maintains project plans, trackers, and regulatory intelligence tools • Assists in development of Regulatory Affairs Specialists and other operational area staff • Provides input into regulatory strategy and timeline development • Participates in maintaining corporate quality initiatives across business units
Requirements
• Bachelor's degree or equivalent experience, ideally in a scientific or healthcare discipline • Computer literacy (MS Office/ Office 365) • Fluent in English • 5+ years or more relevant regulatory affairs experience • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones • Specialized knowledge of regulatory activities for at least one major region (EU, US) • Ability to understand clinical and pre-clinical study results • Knowledgeable of clinical trials methodology • Knowledge and expertise with relevant regulations and guidance • Availability for domestic and international travel
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
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