James Connelly Email & Phone Number
Associate Director Regulatory Affairs - CMC @ Mirum Pharmaceuticals, Inc.
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James Connelly Location
- Philadelphia, PA, US
James Connelly Work
- 2023 - now Associate Director Regulatory Affairs - CMC @
- 2019 - 2023 Associate Director Regulatory Affairs CMC @
- 2018 - 2019 Associate Director Regulatory Affairs CMC @
- 2014 - 2017 Associate Director Regulatory Affairs CMC @
- 2005 - 2014 Manager Global Regulatory Sciences - CMC @
- 2002 - 2005 Manager, Worldwide Regulatory Affairs - CMC @
- 2000 - 2002 Regulatory Affairs Coordinator - CMC @
- 1998 - 2000 Regulatory Affairs Associate - CMC @
- 1996 - 1998 Regulatory Affairs Consultant @
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 5 emails and 2 mobile phone numbers on RocketReach.
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Top Mirum Pharmaceuticals, Inc. Employees
Erin Campany
Chief People Officer
California, United States
Andrew McKibben
Senior Vice President, Strategic Finance and Investor Relations
San Francisco, CA, US
Doug Sheehy
Chief Legal Officer and Secretary
Burlingame, CA, US
Joanne Quan
Chief Medical Officer
San Mateo, CA, US
Paul Ross
Principal and Founder
Nokomis, FL, US
Jonathan D'Augusta
Vice President Marketing
Franklin, TN, US
Cory Kostrub
VP of NonClinical and ClinPharm
California, United States
Darren Hart
Senior Vice President, Clinical Operations
Half Moon Bay, CA, US
Michael Ehrman
Senior Vice President, North America Sales and Marketing
California, United States
Jeanne Loboda
Vice President, Global Patient Advocacy
San Francisco, CA, US
Jean-Luc Girardet
Chief Technical Officer
San Diego, CA, US
Peter Radovich
President and Chief Operating Officer
Burlingame, CA, US
Steve P
Vice President, IT
California, United States
Lara Longpre
Chief Development Officer
Bradenton, FL, US
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