Regulatory Affairs Consultant

Responsibilities

• Manage post-approval regulatory activities including variations, renewals, and compliance with country-specific requirements
• Support regulatory submissions such as MAAs (Marketing Authorization Applications), minor/major variations, and marketing authorization transfers
• Coordinate Module 1 activities for CMC, Safety, Administrative, and other post-approval variations
• Manage submissions through local Health Authority portals and handle regulatory communication via RIMS and Veeva Vault
• Support linguistic review processes, including translation review, coordination, and readability testing
• Assist with promotional material review, artwork approvals, and Abbreviated Product Information (API) updates
• Support Periodic Safety Update Report (PSUR) submissions and country-level regulatory intelligence activities

Requirements

• 7+ years of experience in supporting regulatory submissions (MAAs, variations, renewals, etc.)
• Working knowledge of EU procedures, including centralized procedures coordination and management
• Proficiency with Regulatory Information Management Systems (RIMS) and Veeva Vault
• Experience with Module 1 preparation and post-approval lifecycle management

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. We are dedicated to advancing science with a patient-centric approach, offering a supportive, inclusive, and flexible remote work environment.