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

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

Parexel

Remote (United Kingdom)
20h ago

Parexel is seeking experienced CMC (Chemistry, Manufacturing, and Controls) professionals to join us as a Regulatory Affairs Consultant CMC Author to support our client. This position requires expertise in regulatory affairs, CMC authoring for initial submissions and lifecycle management, and other pharmaceutical documentation for biologics. Previous experience working with biologics products is a must.

The role can be home or office based in various European locations.

Role Responsibilities

• Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
• Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products.
• Experience preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs, and supportive clinical amendments and post approval supplements/variations. (ICH Modules 2 and/or 3)
• Write scientific rationales to support regulatory answers, variations, and dossier submissions
• Coordinate CMC activities across multiple projects and manage timelines effectively
• Thorough understanding of change management processes and regulatory requirements.
• Build and assess 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 database with current regulatory information
• Provide ad-hoc CMC consulting support and technical advice