Regulatory Affairs Consultant – CMC author biologics (home or office based)

Overview

Parexel seeks experienced CMC professionals to join as Regulatory Affairs Consultant CMC Author, supporting clients in regulatory affairs and CMC authoring for biologics. The role is remote or office-based across Europe and involves authoring IND/IMPDs, BLA/NDA/MAAs, and lifecycle management. You will coordinate CMC activities, develop regulatory strategies, and provide technical advice. You will work with cross-functional teams to drive regulatory success and ensure compliance, contributing to therapies that benefit patients.

Responsibilities

• Understand the drug development process across all phases and apply regulatory guidelines to maximize success and compliance
• Master global regulations and ICH guidance for development and lifecycle management of NCE/NME products
• Prepare CMC sections of IND/IMPDs, BLA/NDA/MAAs, and amendments and variations
• Write rationales to support regulatory answers, variations, and submissions
• Coordinate CMC activities across multiple projects and manage timelines
• Understand change management processes and regulatory requirements
• Develop regulatory strategies for variations and registrations based on affiliate information and EU/US guidelines
• Develop regulatory strategy for medical devices part of combination products
• Update and maintain regulatory information databases
• Provide ad-hoc CMC consulting support and technical advice

Key requirements

• 10+ years of pharmaceutical industry experience in CMC and regulatory affairs
• Strong expertise in CMC for biologicals – initial submissions and lifecycle maintenance
• Comprehensive understanding of ICH guidelines and EU/US regulatory guidelines
• Strong problem solving and diplomacy skills
• Ability to manage multiple projects simultaneously and meet deadlines
• Experience with Veeva or similar document management systems
• Fluent English (written and spoken); additional European languages advantageous

• problem solving
• diplomacy
• multitasking/ project management
• CMC for biologicals
• IND/IMPDs preparation
• BLA/NDA/MAAs preparation

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