Regulatory Affairs Consultant @ (June 1996 - April 1998)
James Connelly Education
Drexel University
Bachelor of Science (B.Sc.)
James Connelly Skills
Regulatory Strategy Development
Attention to Detail
Organization Skills
Oral Communication
ICH
Compliance Regulations
New Drug Application (NDA)
Common Technical Document (CTD)
Global Regulatory Compliance
Communication
Pharmaceutical Industry
Regulatory Affairs
Regulatory Submissions
GMP
Biotechnology
Clinical Trials
Oncology
Sop
FDA
Clinical Development
Biopharmaceuticals
21 CFR Part 11
Pharmacovigilance
Technology Transfer
Regulatory Requirements
Drug Development
Validation
CAPA
GCP
Change Control
Vaccines
eCTD
CMC
IND
Drug Discovery
Standard Operating Procedure (SOP)
FDA GMP
Regulatory Compliance
CMC development
U.S. Food and Drug Administration (FDA)
Electronic Common Technical Document (eCTD)
CMC Regulatory Affairs
Corrective and Preventive Action (CAPA)
U.S. Title 21 CFR Part 11 Regulation
Leadership
Social Media
Event Planning
Strategic Planning
Corrective And Preventive Action Capa
U.S. Food And Drug Administration Fda
Electronic Common Technical Document Ectd
Standard Operating Procedure Sop
Standard Operating Procedure
u.s. Food and Drug Administration
Electronic Common Technical Document
Corrective and Preventive Action
James Connelly Summary
James Connelly, based in Philadelphia, PA, US, is currently a Associate Director Regulatory Affairs - CMC at Mirum Pharmaceuticals, Inc.. James Connelly brings experience from previous roles at Jazz Pharmaceuticals, Bausch Health Companies Inc., Eisai US and Bristol-Myers Squibb. James Connelly holds a Bachelor of Science (B.Sc.) @ Drexel University. With a robust skill set that includes Regulatory Strategy Development, Attention to Detail, Organization Skills, Oral Communication, ICH and more. James Connelly has 4 emails and 3 mobile phone numbers on RocketReach.
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