James Connelly
Associate Director Regulatory Affairs - Cmc @Mirum Pharmaceuticals, Inc.
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WORK HISTORY
Associate Director Regulatory Affairs - Cmc @Mirum Pharmaceuticals, Inc.
US
Support RA CMC with the filing of original and post-approval international registrations.• Ensure CMC dossiers meet ICH requirements, as well as country specific requirements.• Manage and maintain regulatory CMC submission tracker and documents for global dossier management at initial application and post-approval stages.• Performs CMC Regulatory Operations activities to assure a smooth submission process.• Support authoring of meeting requests, briefing documents, responses to health authority inquiries, IND/IMPD amendments, post approval changes, and relevant annual updates.• Development and implementation of CMC regulatory strategy for global market applications.• Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, change control management, and product and compliance quality initiatives.• Support the preparation of risk assessments on CMC regulatory topics and quality change control management.
EDUCATION
Drexel University
Bachelor of Science (B.Sc.)
SKILLS
ABOUT JAMES CONNELLY
Associate Director Regulatory Affairs - CMC
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