Regulatory Affairs Manager – CMC biologics (various European locations) Full Time

Summary:

Parexel, a global CRO with over 16,000 employees across 100+ countries, seeks a Regulatory Affairs Manager – CMC Biologics. Headquartered in Boston and Durham, Parexel supports drug development worldwide. The role, based in various European locations, focuses on post-approval CMC regulatory activities for biological products, ensuring compliance and patient benefit.

Responsibilities:

• Develop submission strategies and plans for post-approval CMC activities such as 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 the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Requirements:

• University-level education, preferably in Life Sciences, or equivalent by experience.
• Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
• Knowledge of biological processes.
• Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation.
• Understanding of qualification/validation principles.
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.
• Fluent in English (written and spoken).
• French, Italian and German would be a strong plus.