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Michael Bernhard Email & Phone Number

Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals at MedPointe Pharmaceuticals
Location: Summit, New Jersey, United States 9 work roles 3 schools
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Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals
Location
Summit, New Jersey, United States
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Who is Michael Bernhard? Overview

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Michael Bernhard is listed as Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals at MedPointe Pharmaceuticals, a with 56 employees, based in Summit, New Jersey, United States. AeroLeads shows a matched LinkedIn profile for Michael Bernhard.

Michael Bernhard previously worked as Senior Director and Head, Regulatory Affairs at Medpointe Pharmaceuticals and Senior Director and Head, Regulatory Affairs at Ferring Pharmaceuticals. Michael Bernhard holds Ms, Transplantation Immunology from New York University.

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MedPointe Pharmaceuticals

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About Michael Bernhard

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

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MedPointe Pharmaceuticals
Medpointe Pharmaceuticals
Senior Director and Head, Regulatory Affairs at MedPointe Pharmaceuticals
united states
Employees
56
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9 roles · 47 years

Michael Bernhard work experience

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Senior Director And Head, Regulatory Affairs

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).

1999 - 2005 ~6 yrs

Cso And Vp, Pharmaceutical Development

Fei Technologies

Established new programs for drug-device combinations in field of women's health (infertility, contraception, incontinence, etc.)

1998 - 1999 ~1 yr

Director, R&D

Becton Dickinson Transdermal Systems

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.

1995 - 1998 ~3 yrs

Vice Presdient, Product Development

Block Drug Company, Reed And Carnrick Division

Developed new Rx and OTC products

1992 - 1995 ~3 yrs

Director, Regulatory Affairs

Block Drug Company, Reed And Carnrick Division

Regulatory affairs for ethical drug products: NDAs, ANDAs, INDs, FDA inspections, etc.

1990 - 1992 ~2 yrs

Director, Regulatory Affairs

One of 3 directors in department, handled all drug regulatory affairs for 35% of Schering's products.

1983 - 1990 ~7 yrs

Assistant General Manager

Coulter Immunology

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.

1982 - 1983 ~1 yr

Acting Section Chied

Established and ran the monoclonal antibody laboratory of the Biological Response Modifiers Program to develop tumor diagnostic and therapeutic monoclonal antibody treatments.

1980 - 1982 ~2 yrs
3 education records

Michael Bernhard education

Ms, Transplantation Immunology

Activities and Societies: Established and ran tissue typing laboratory for first kidney transplant center in New York City

FAQ

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What company does Michael Bernhard work for?

Michael Bernhard works for MedPointe Pharmaceuticals.

What is Michael Bernhard's role at MedPointe Pharmaceuticals?

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

Where is Michael Bernhard based?

Michael Bernhard is based in Summit, New Jersey, United States while working with MedPointe Pharmaceuticals.

What companies has Michael Bernhard worked for?

Michael Bernhard has worked for Medpointe Pharmaceuticals, Ferring Pharmaceuticals, Fei Technologies, Becton Dickinson Transdermal Systems, and Block Drug Company, Reed And Carnrick Division.

How can I contact Michael Bernhard?

You can use AeroLeads to view verified contact signals for Michael Bernhard at MedPointe Pharmaceuticals, including work email, phone, and LinkedIn data when available.

What schools did Michael Bernhard attend?

Michael Bernhard holds Ms, Transplantation Immunology from New York University.

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