Katalyst HealthCares & Life Sciences
Senior Manager, Regulatory Affairs
Katalyst HealthCares & Life Sciences, Charlotte, North Carolina, United States, 28245
Senior Manager, Regulatory CMC Technical Writing and Submission Management
Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings. This role requires a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements, while collaborating with cross-functional teams to ensure timely and accurate submissions.
Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings. This role requires a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements, while collaborating with cross-functional teams to ensure timely and accurate submissions.