For over 22 years Jennifer Kelley has been working in different jobs. Recently, the professional worked as a Pre-Approval Manager - Regulatory Affairs in Huvepharma, Inc enhancing knowledge. This professional graduated from Northeastern University in 2010 where the professional received all the necessary knowledge. You can find this person in Easton, Pennsylvania, where he lives nowadays. SoftwareOfficial has all the personal info you need to contact Jennifer Kelley, such as this person's number or email address. Feel free to send the request to get additional info.
Name variants:
Jen Kelley,
Jenny Kelley,
Jennie Kelley,
Jenne Kelley,
Jan Kelley
Last updated May 26, 2024
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Work History
Pre-Approval Manager - Regulatory Affairs
St, Louis, MO
Leader on pre-approval projects working collaboratively with internal and external stakeholders
Develop regulatory strategy to align with business goals
Write detailed technical reports, ...
from May 2017
Senior Manager Regulatory Affairs
Manage the preparation of both original and subsequent regulatory documents related to biomedical technical sections of animal drug applications
Manage RA team members
Determine risk asse...
Nov 1, 2012 — Mar 2015
Regulatory Affairs Manager
2940 Hwy #360, Grand Prairie, TX
May 2007 — Nov 2012
Online Instructor and Teaching Assistant
360 Huntington Ave, Boston, MA 02136
Teach or assist teaching graduate-level courses for the Master of Science in Regulatory Affairs of Drugs, Biologics, and Medical Devices. Instructional areas include clinical trial managemen...
from Apr 2011
Validation Specialist
Wrote and executed protocols for equipment and process validations including protocol summary reports - compiling and reviewing data.
Composed and revised validation SOPs.
Audited complet...
May 2006 — May 2007
Associate Attorney and Legal Assistant
Performed legal research and case analysis. Prepared pleadings, discovery requests, discovery responses, correspondence, reports, and memos. Negotiated settlements for personal injury claim...
Nov 2000 — May 2006
Quality Assurance Engineer
7000 Cardinal Pl, Dublin, OH 43017
Investigated and prepared reports on the root cause of consumer complaints, deviations from procedures, results failures, and uncommon incidents during production.
Wrote/revised SOPs and D...
Aug 2004 — Jun 2005
Microbiology Research Technician
700 Anderson Hill Rd, Purchase, NY 10577
Tested food ingredients for microbial quality.
Verified food facility environmental samples for sanitation quality.
Trained new employees.
Apr 1998 — Nov 2000
Microbiologist
1000 Mylan Blvd, Canonsburg, PA
Performed microbial limits test on raw materials and finished products, penicillin contamination tests, antimicrobial preservative tests, and antibiotic potency assays. Validated microbial ...
Sep 1993 — Oct 1997
Education
2008 — 2010
1998 — 2002
1988 — 1992
Occupations
Executive
Manager
Leader
Senior Manager
IT Professional
Technical Support Specialist
Operations Manager
Managers
Systems Support Specialist
Support Specialists
Skills
Gmp
Fda
Regulatory Affairs
Pharmaceutical Industry
Regulatory Submissions
Quality Assurance
Validation
Sop
Clinical Trials
Clinical Development
Capa
Biotechnology
Microbiology
R&D
Change Control
V&V
U.s. Food and Drug Administration
Drug Development
Quality System
Quality Control
Formulation
Regulatory Requirements
Medical Devices
Pharmaceutics
Life Sciences
Cross Functional Team Leadership
Chemistry
Ind
Standard Operating Procedure
Gcp
Analytical Chemistry
Lifesciences
Glp
Good Laboratory Practice
Lims
Anda
Nda
Verification and Validation