Responsibilities:
uthor and review high-quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings) and support client in responding to health authority questions within defined timelines.
Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
ssesses currently registered content, proposed changes, and justification for changes by utilizing client's change control system during pre-submission planning.
Responsible for regulatory operational activities including organizing, tracking, and sending submissions to publishing team for US and other international markets.
Compiles documentation for regulatory submission packages including license renewals, updates and market registration for review and submission to regulatory agencies.
Liase with client and client partners to collect the needed sources; communicate any issues or risks proactively.
Ensures compliance with FDA, EMA, and global regulatory requirements; assures the quality of the investigational and commercial drug substances and drug products.
Perform technical review of certificate of analysis, analytical test methods, specification, product development reports, Master Batch Records (MBR), validation protocol/report, and stability protocol/report/data.
Work within multiple regulatory systems and tools during end-to-end submission process.
Maintains knowledge of current FDA, EU, global regulations, and guidance applicable to marketed products.
Support and prepare other CMC ad-hoc requests as per client requests.
Requirements:
Bachelor's degree in a health or life science discipline is required; Advanced degree is preferred.
5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
2+ years of experience in Regulatory-CMC.
bility to read, analyze and interpret technical documents and health authority regulations.
Demonstrated experience authoring CMC sections in Module 1, 2 and 3 sections of regulatory filings required.
Familiar with Common Technical Document (CTD) formatting.
Working knowledge of the US and European regulations and ICH guidance is preferred.
Demonstrated experience using regulatory systems and tools (e.g., TrackWise and Veeva Vault are preferred.
Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).
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