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

Parexel is seeking experienced CMC (Chemistry, Manufacturing, and Controls) professionals to join us as a Regulatory Affairs Consultant CMC Author to supportourclient. This position requires expertise in regulatory affairs, CMCauthoring for initial submissions andlifecycle management, andotherpharmaceutical documentation forbiologics. 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

Required Qualifications & Skills

• University degree in Chemistry, Pharmacy, Chemical Engineering, or related pharmaceutical field
• 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 withVeevaor similar document management systems
• Fluent English (written and spoken); Additional European languages (French, German, Spanish) are advantageous

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