Regulatory Affairs Associate

Responsibilities

• Support global regulatory lifecycle management activities across EU, US, and international markets
• Contribute to regulatory strategy development for global and regional submissions
• Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5)
• Manage post-approval changes, variation submissions, and follow-up activities
• Handle Health Authority queries and ensure timely responses
• Provide submission management support including planning, coordination, and timeline tracking
• Maintain accurate records in Regulatory Information Management (RIM) systems
• Support safety-related regulatory activities such as aggregate reports and urgent safety updates
• Assist with audit, compliance, and inspection readiness activities

Requirements

• B.Sc. / M.Sc. or B. Pharmacy / M. Pharmacy degree
• 2 to 4 years of relevant regulatory experience
• Strong knowledge of EU & US regulatory procedures and post-approval requirements
• Experience in global submission management and lifecycle maintenance
• Understanding of regulatory documentation and compliance standards
• Strong coordination and stakeholder management skills

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 work environment that fosters professional growth and innovation.