Senior Regulatory Manager - Remote

Overview

The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations.

In Short

• 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
• Serve as representative of Global Regulatory Affairs at project team meetings
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists
• Maintenance of project plans and regulatory intelligence tools
• Assist in development of Regulatory Affairs Specialists
• Provide input into regulatory strategy and timeline development
• Participates in maintaining corporate quality initiatives

Requirements

• Bachelors degree in a scientific or healthcare discipline
• 5 years Regulatory experience required for the Manager level
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• Regulatory affairs experience working for a Clinical Research Organisation
• Informed knowledge of drug development process
• Ability to understand clinical and pre-clinical study results
• Knowledgeable of clinical trials methodology
• Knowledge and expertise with relevant regulations
• Availability for domestic and international travel

Benefits

• Opportunity to impact positive change for the company
• Work with a passionate team in precision medicine
• Contribute to groundbreaking cancer therapies
• Professional development opportunities
• Flexible work environment