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 4 emails and 3 mobile phone numbers on RocketReach.
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