Regulatory Manager - Remote

Overview

The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.

In Short

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, and marketing applications
• Develops and/or reviews documents intended for submission to the Regulatory Authorities
• Serve as representative of Global Regulatory Affairs at project team meetings
• Works within a project team, and leads projects as necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintenance of project plans and regulatory intelligence tools
• Assist in development of Regulatory Affairs Specialists and other operational staff
• Participates in maintaining corporate quality initiatives
• Provides ICH GCP guidance and training to clients

Requirements

• Bachelors degree in a scientific or healthcare discipline
• 5+ years of relevant regulatory affairs experience
• Informed knowledge of the drug development process
• Specialized knowledge of regulatory activities for major regions (EU, US)
• Ability to understand clinical study results
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• Availability for domestic and international travel

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation