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Regulatory CMC Coordinator at ICON plc (UK Remote)
Support pharmaceutical CMC submissions at ICON plc through document coordination, regulatory record management, and data oversight. This remote role covers UK and Poland-based activities.
विवरण
- Support the compilation, upkeep, and quality review of CMC submission documents, including IMPDs, Module 2.3 and Module 3 content, and Clinical Trial Applications (CTAs)
- Develop and monitor CMC submission plans, manufacturing data, response documents, forms, cover letters, and related materials in regulatory systems
- Keep regulatory documents in electronic, submission-ready formats and assist with assembling complete submission packages
- Maintain regulatory records, master and country-specific IMPD binders, GMP certificates, Manufacturing Import Authorizations (MIAs), and related compliance files
- Review and reconcile regulatory data, dossier content, submission trackers, and system metadata
- Work with Regulatory CMC Leads, Regulatory Operations, and cross-functional partners on workflow reviews, approvals, and regulatory changes
- Support regulatory information management activities in RIM platforms while following internal procedures and regulatory obligations
आवश्यकताएँ
- Bachelor’s degree in life sciences or a related scientific field
- Background supporting regulatory submissions, Clinical Trial Applications (CTAs), CMC work, or regulatory operations in the pharmaceutical, biotechnology, or CRO sector
- Working knowledge of regulatory materials such as IMPDs, GMP documentation, and electronic submission workflows
- Experience using electronic document management or regulatory information management systems, including Veeva RIM or comparable platforms
- Strong organizational, communication, and data management abilities, with accuracy when handling multiple concurrent activities
- Familiarity with eCTD requirements, document publishing standards, or electronic submission environments is preferred
- Experience with regulatory databases, submission tracking applications, and regulatory information management systems is preferred
- Comfort working in AI-enabled environments and using technology to improve operational efficiency is preferred
- Legal authorization to work in the country where the role is based
लाभ
- Competitive base pay with performance-related incentives
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable
- Retirement and pension arrangements
- Life assurance and disability protection
- Employee assistance programs and wellbeing resources
- Structured training and career development opportunities
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