James Connelly
Associate Director Regulatory Affairs - CMC at Mirum Pharmaceuticals, Inc. | Greater Philadelphia
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Associate Director Regulatory Affairs - CMC at Mirum Pharmaceuticals, Inc. in December 2023 to Present
Associate Director Regulatory Affairs CMC at Jazz Pharmaceuticals in October 2019 to August 2023
Associate Director Regulatory Affairs CMC at Bausch Health Companies Inc. in January 2018 to October 2019
Associate Director Regulatory Affairs CMC at Eisai US in June 2014 to November 2017
Manager Global Regulatory Sciences - CMC at Bristol-Myers Squibb in July 2005 to June 2014
Manager, Worldwide Regulatory Affairs - CMC at Janssen Inc. in January 2002 to July 2005
Regulatory Affairs Coordinator - CMC at Wyeth Pharmaceuticals in September 2000 to January 2002
Regulatory Affairs Associate - CMC at Bristol-Myers Squibb in April 1998 to September 2000
Regulatory Affairs Consultant at ConvaTec in June 1996 to April 1998
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Drexel University, Bachelor of Science (B.Sc.)
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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
SOP
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
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Discover more about Mirum Pharmaceuticals, Inc.What is James Connelly email address?
Email James Connelly at [email protected] and [email protected]. This email is the most updated James Connelly's email found in 2026.
What is James Connelly phone number?
James Connelly phone number is 8563840390.
How to contact James Connelly?
To contact James Connelly send an email to [email protected] or [email protected]. If you want to call James Connelly try calling on 8563840390.
What company does James Connelly work for?
James Connelly works for Mirum Pharmaceuticals, Inc.
What is James Connelly's role at Mirum Pharmaceuticals, Inc.?
James Connelly is Associate Director Regulatory Affairs - CMC
What industry does James Connelly work in?
James Connelly works in the Pharmaceuticals industry.
James Connelly Email Addresses
James Connelly Phone Numbers
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