Tech Digital
Scientific - Global Regulatory CMC Manager
Tech Digital, Lawrence Township, New Jersey, United States, 08648
Job Title
Responsibilities will include, but are not limited to, the following: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authority...
Responsibilities will include, but are not limited to, the following: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authority...