Senior 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

• 5 to 8 years of relevant regulatory affairs 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
• B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy degree

Preferred Qualifications

• Strong coordination and stakeholder management skills
• Experience working within a consulting model or client-facing environment

Benefits

• Flexible remote work arrangements
• Opportunities for career growth and professional development
• Mentorship from highly experienced regulatory professionals
• Exposure to diverse product types and therapeutic areas

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes to bring life-changing products to market. We value collaboration, innovation, and a patient-centric approach in everything we do.