Michael Bernhard

Michael Bernhard Email and Phone Number

Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals @ MedPointe Pharmaceuticals
united states
Michael Bernhard's Location
Summit, New Jersey, United States, United States
About Michael Bernhard

Michael Bernhard is a Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals at MedPointe Pharmaceuticals.

Michael Bernhard's Current Company Details
MedPointe Pharmaceuticals

Medpointe Pharmaceuticals

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Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals
united states
Employees:
56
Michael Bernhard Work Experience Details
  • Medpointe Pharmaceuticals
    Senior Director And Head, Regulatory Affairs
    Medpointe Pharmaceuticals
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  • Ferring Pharmaceuticals
    Senior Director And Head, Regulatory Affairs
    Ferring Pharmaceuticals 1999 - 2005
    Established regulatory affairs department for this international company in the US. Filed 5 new INDs, many IND amendments and NDA supplements, 4 NDAs filed and approved and 2 additional filed. Obtained 510k for 2 medical devices. Concentration: biologically derived hormone products for women's health (infertility).
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  • Fei Technologies
    Cso And Vp, Pharmaceutical Development
    Fei Technologies 1998 - 1999
    Established new programs for drug-device combinations in field of women's health (infertility, contraception, incontinence, etc.)
  • Becton Dickinson Transdermal Systems
    Director, R&D
    Becton Dickinson Transdermal Systems 1995 - 1998
    Directed R&D, computer sciences, analytical labs, regulatory affairs, adhesives, pilot plant, support of clinical studies worldwide and member of design group for manufacturing plant for developing iontophoretic drug delivery systems. Due diligence, licensing and acquisitions, contracting, liaison with partners, conducted first in man clinical trials. 5 patents issued.
  • Block Drug Company, Reed And Carnrick Division
    Vice Presdient, Product Development
    Block Drug Company, Reed And Carnrick Division 1992 - 1995
    Developed new Rx and OTC products
  • Block Drug Company, Reed And Carnrick Division
    Director, Regulatory Affairs
    Block Drug Company, Reed And Carnrick Division 1990 - 1992
    Regulatory affairs for ethical drug products: NDAs, ANDAs, INDs, FDA inspections, etc.
  • Schering-Plough
    Director, Regulatory Affairs
    Schering-Plough 1983 - 1990
    One of 3 directors in department, handled all drug regulatory affairs for 35% of Schering's products.
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  • Coulter Immunology
    Assistant General Manager
    Coulter Immunology 1982 - 1983
    Assisted in establishing and running this monoclonal antibodydivision for the diagnosis and treatment of tumors with monoclonal antibodies and developing monoclonals for identifying various blood cells for fluorescent activated cell sorting.
  • National Cancer Institute
    Acting Section Chied
    National Cancer Institute 1980 - 1982
    Established and ran the monoclonal antibody laboratory of the Biological Response Modifiers Program to develop tumor diagnostic and therapeutic monoclonal antibody treatments.
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Michael Bernhard Education Details

Frequently Asked Questions about Michael Bernhard

What company does Michael Bernhard work for?

Michael Bernhard works for Medpointe Pharmaceuticals

What is Michael Bernhard's role at the current company?

Michael Bernhard's current role is Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals.

What schools did Michael Bernhard attend?

Michael Bernhard attended New York University, Cornell University, Tufts University.

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