Kevin P Malobisky

Chief Regulatory and Strategic Operations Officer

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:
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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

Associate Vice President, Global Regulatory Affairs

from Jul 2010

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

Associate Director

Jun 2003 — Oct 2004

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

Assistant Director, Regulatory Affairs

Nov 1998 — Jun 2000

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

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.
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