Regulatory Affairs CMC Manager

A company is looking for a Regulatory Affairs CMC Sr. Manager. Key Responsibilities Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products Works with external stakeholders including regulatory agencies to influence global regulatory policy Identifies regulatory risks and ensures aligned plans for mitigation across products Required Qualifications Doctorate degree OR Master's degree and 3 years of related experience OR Bachelor's degree and 5 years of related experience OR Associate's degree and 10 years of related experience OR High school diploma/GED and 12 years of related experience Experience in manufacturing, testing (QC/QA or clinical), or distribution is preferred Regulatory CMC experience is preferred Staff management and development experience Specific regulatory knowledge and experience in CMC

Apr 10, 2025 - 18:02

A company is looking for a Regulatory Affairs CMC Sr. Manager. Key Responsibilities Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products Works with external stakeholders including regulatory agencies to influence global regulatory policy Identifies regulatory risks and ensures aligned plans for mitigation across products Required Qualifications Doctorate degree OR Master's degree and 3 years of related experience OR Bachelor's degree and 5 years of related experience OR Associate's degree and 10 years of related experience OR High school diploma/GED and 12 years of related experience Experience in manufacturing, testing (QC/QA or clinical), or distribution is preferred Regulatory CMC experience is preferred Staff management and development experience Specific regulatory knowledge and experience in CMC