Regulatory Affairs Consultant - CMC author biologics (home or office based)
Description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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 :
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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.
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Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products.
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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)
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Write scientific rationales to support regulatory answers, variations, and dossier submissions
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Coordinate CMC activities across multiple projects and manage timelines effectively
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Thorough understanding of change management processes and regulatory requirements.
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Build and assess regulatory strategies for variations and registrations based on affiliate information and EU/US guidelines
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Develop regulatory strategy for medical devices part of combination products
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Update and maintain database with current regulatory information
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Provide ad-hoc CMC consulting support and technical advice
Required Qualifications & Skills
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University degree in Chemistry, Pharmacy, Chemical Engineering, or related pharmaceutical field
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10+ years of pharmaceutical industry experience in CMC and regulatory affairs
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Strong expertise in CMC for biologicals – initial submissions and Lifecycle maintenance
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Comprehensive understanding of ICH guidelines and EU/US regulatory guidelines
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Strong problem solving and diplomacy skills
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Ability to manage multiple projects simultaneously and meet deadlines
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Experience with Veeva or similar document management systems
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F luent English (written and spoken); Additional European languages (French, German, Spanish) are advantageous