Kevin P Malobisky is a high-level expert, who works in sanofi-aventis on the position of Associate Vice President, Global Regulatory Affairs since 2010. This person gained professional experience in more than 13 positions at different companies. Kevin P Malobisky went to the Capella University and got education from 2009 to 2011. This person has the following qualifications: Rac-Us. Philadelphia, Pennsylvania is the city, where this person was known to be located. The person's email address and phone are easily accessed through Connexy by request.
Name variants:
Kev Malobisky
Contact Information
Last Update
Jul 10, 2022
Email
ke**@sanofi-aventis.com
Location
Philadelphia, PA
Company
sanofi-aventis
Workplace
Associate Vice President, Global Regulatory Affairs
Work History
Regional Head, U.S. & Canada; TSU Head, Fibrosis & Wound Repair; Global Regulatory Affairs
from Feb 2010
Senior Director & Global Axis Head
Global Axis Head-Metabolism
U.S. regulatory management responsibilities for metabolism axis including hiring and training of staff, budget and planning responsibilities, and performance ...
Feb 2006 — 2010
Therapeutic Head
Lead liaison and global regulatory leader for rimonabant project
Global leader of FDA response team and member of advisory committee team
Corporate regulatory leader with Canadian affiliate-...
Oct 2004 — Feb 2006
Assistant Director
U.S. regulatory team leader for NME rimonabant eNDA/CTD submission
Provide regulatory strategy and guidance to multiple global project teams in areas of both non-clinical and clinical drug d...
Jun 2000 — Jun 2003
Manager, Regulatory Affairs
Successfully led submission and regulatory filing of electronic new drug application for unique purgative product in the Division of Gastrointestinal Products at FDA
Prepared and managed all...
Nov 1997 — Nov 1998
Manager
Clinical Responsibilities:
Spearheaded the development and organization of the clinical and regulatory department.
Successful development of clinical protocols, case report forms, and regula...
Dec 1996 — Nov 1997
Senior Clinical Research Associate
Provided clinical support to multiple pharmaceutical sponsors for Phase I-III clinical investigations
Responsible for conducting routine pre-study, monitoring and close-out evaluations at mu...
Jul 1996 — Nov 1996
Regulatory Affairs Associate
Prepared and submitted Premarket Approvals, 510(k) submissions and Investigational New Drug applications for class II and III in-vitro diagnostic devices with CDER and CBER
Prepared and subm...
Feb 1995 — Apr 1996
Assistant Scientist
Developed and validated both a qualitative and a quantitative DNA PCR assay for use in Phase I clinical evaluations of anti-human immunodeficiency virus compounds
Prepared and sequenced high...
Jan 1990 — Feb 1992
Assistant Scientist
Performed multiple DNA restriction experiments on newly designed DNA plasmids
Constructed various DNA restriction maps for use in the development of vector experiments
Assisted in the sequen...
Jun 1988 — Aug 1988
Education
2009 — 2011
1998 — 2000
from 1989
Occupations
Operations Officer
Executive
Assistant Vice President
Operations Manager
Vice President
Chief Executive
Skills
Regulatory Affairs
Pharmaceutical Industry
Clinical Development
Regulatory Submissions
Fda
Clinical Trials
Raps
Oncology
Regulatory Requirements
Gcp
Gmp
Sop
Biotechnology
Pharmacovigilance
Ind
Ctms
Technology Transfer
Biopharmaceuticals
Cro
Medical Devices
Pharmaceutics
Clinical Research
Lifesciences
Ectd
Diabetes
Drug Development
Medical Writing
R&D
Therapeutic Areas
Glp
Assay Development
21 Cfr Part 11
Strategy
Management
Drug Discovery
Leadership
Life Sciences
Standard Operating Procedure
U.s. Food and Drug Administration
FAQs about Kevin P Malobisky
What's the profession of Kevin P Malobisky?
This professional's job is Chief Regulatory and Strategic Operations Officer
What jobs is Kevin proficient at at?
Kevin is a professional Operations Officer jobs.
Where does Kevin P Malobisky currently live?
Kevin currently lives in Philadelphia, Pennsylvania.
Does Kevin have the email address?
ke**@sanofi-aventis.com is The professional's email address.
How many companies did Kevin P Malobisky work at?
Kevin P Malobisky worked at 13 jobs.
What education does Kevin P Malobisky have?
Kevin studied at the Capella University from 2009 to 2011.
What are the certifications of Kevin P Malobisky?
This expert received the following certifications: Rac-Us.
Are there any industries Kevin P Malobisky works in?
Kevin works in Pharmaceuticals industry.