Noel Philip
Cmc Regulatory Affairs Associate @阿斯利康
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WORK HISTORY
Cmc Regulatory Affairs Associate @阿斯利康
Responsible for providing support in the collection, evaluation, preparation, and assembly of Chemistry, Manufacturing and Control (CMC) documentation required for submissions to support both original marketing applications and maintenance of existing licenses for marketed products including post approval submissions. Part of a dynamic team that works closely with relevant product and project teams providing regulatory and compliance advice as appropriate. Ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to updates of policy and processes as appropriate. Job Responsibilities: • Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components. • Support and delivery of submission ready packages to agreed timelines and management of information required. • Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications. • Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables. • Develop research skills relevant information, regulations, and guidance from different regulatory agencies. • Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination. • Assist in the preparation of agendas, presentations, and other supporting materials for various meetings. • Contribute to the development and improvement of related business processes. • Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required. • Ensure the learning from own projects are shared with other colleagues/within the functions.
EDUCATION
The Manchester Metropolitan University
Master of Chemistry
Career Ready
Science
The Manchester Metropolitan University
Master of Chemistry
SKILLS
ABOUT NOEL PHILIP
Regulatory Affairs Associate working in the Chemistry, Manufacturing and Controls (CMC)…
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