Katalyst Healthcares & Life Sciences
Location: Matthews,NC, USA
Date: 2024-12-05T08:37:58Z
Job Description:
Responsibilities:
- Author 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.
- 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.
- 5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
- 2+ 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 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).