Regulatory Affairs Consultant - CMC author biologics (home or office based)
United Kingdom, Remote Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Lithuania, Remote; Lithuania, Vilnius; Poland, Remote; Poland, Warsaw; Romania, Bucharest; Romania, Remote; Serbia, Belgrade; Serbia, Remote 职位编号 R0000045277 类别 Regulatory / Consulting关于这个职位
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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