Regulatory Affairs Consultant

Responsibilities

• Develop submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports
• Assess change controls and provide regulatory assessments of quality changes in production and quality control
• Review study reports from quality control and production departments to ensure compliance with regulatory requirements
• Coordinate submission preparation with manufacturing, supply chain, quality control, quality assurance, and other regulatory departments
• Write and review submission content to ensure alignment with regulatory requirements, specifically regarding variations and health authority inquiries
• Manage projects within Regulatory Information Management systems to maintain worldwide submissions
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities

Requirements

• University-level education in Life Sciences or equivalent experience
• Previous experience in regulatory affairs, specifically related to technical, CMC, or quality within the pharmaceutical industry
• Strong understanding of CMC and post-approval regulatory requirements
• Experience writing CMC technical sections of regulatory documents, such as registration files or variations
• Essential knowledge of vaccines or biological processes
• Background in validation, Quality Assurance, or production in the pharmaceutical industry
• Proficiency in Microsoft Word, PowerPoint, and Excel
• Fluent in written and spoken English

Preferred Qualifications

• Experience with Veeva Vault
• Understanding of qualification and validation principles

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 life-changing products to market through scientific expertise, innovation, and a patient-first culture.