CMC Regulatory Affairs Associate

Responsibilities

• Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs
• Prepare and review CMC packages and support GMP submissions
• Manage CMC submissions including planning, package compilation, and responding to Health Authority queries
• Coordinate submission activities such as tracker updates, timeline agreements, and eCTD sequence reviews
• Act as the primary GRA point of contact for Local Regulatory Affairs (LRA) and other stakeholders
• Evaluate scientific CMC information for accuracy and compliance with regulatory requirements
• Manage change control assessments and ensure compliance with client SOPs

Requirements

• University degree in biological sciences, health sciences, or a related field (Regulatory Affairs degree preferred)
• Minimum of 5 years of experience in the biotech or pharmaceutical industry
• Mandatory experience with biological products and vaccines
• Mandatory M3 authoring experience
• Strong technical regulatory expertise in at least one key region: US, EU, Japan, Switzerland, or Australia

Preferred Qualifications

• Experience in Regulatory CMC writing and evaluating technical scientific information
• Knowledge of Good Manufacturing Practice (GMP) or related areas

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 bringing important medical advancements to patients worldwide through expertise, innovation, and a patient-led approach.