CMC Regulatory Affairs Specialist

Responsibilities :

• Author and review high-quality, compliant CMC regulatory documents (, 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.
• Assesses 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 :

• A Bachelor's degree in a health or life science discipline is required; Advanced degree is preferred.
• years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
• years of experience in Regulatory-CMC.
• Ability to read, analyze and interpret technical documents and health authority regulations.
• Demonstrated experience authoring CMC sections in Module , and 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 (, TrackWise and Veeva Vault are preferred.
• Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).
21 days ago