Katalyst Healthcares & Life Sciences
Global Regulatory CMC Manager
Katalyst Healthcares & Life Sciences, Summit, New Jersey, United States, 07901
Job Title
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authority. Focus on the core content of the job post, removing extra metadata from the top of the page. Remove hanging information like department, location, job_id, requisition_id, and others. Remove any extra mentions of description, job details, job post, etc. At the top of the page, remove obvious/redundant headers and dive into the important content. Remove any mention of posted date/time, all requisition numbers, all mentions of "read more" or "website" or "linkedin", all emojis and special characters, mentions of website cookies and page load errors, and any extra spacing. Make it condensed and beautiful to read.
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authority. Focus on the core content of the job post, removing extra metadata from the top of the page. Remove hanging information like department, location, job_id, requisition_id, and others. Remove any extra mentions of description, job details, job post, etc. At the top of the page, remove obvious/redundant headers and dive into the important content. Remove any mention of posted date/time, all requisition numbers, all mentions of "read more" or "website" or "linkedin", all emojis and special characters, mentions of website cookies and page load errors, and any extra spacing. Make it condensed and beautiful to read.