Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Consultant - CMC author biologics (home or office based)
Job ID R0000045277 , United KingdomParexel 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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