Susan Witham work email
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Susan Witham personal email
Over 30 years in the pharmaceutical industry. I have restructured RA, QA, and QC teams that have successfully achieved approvals for NCE's, ANDAs, and have adequately addressed major FDA 483's. Helped build strong relationships with FDA Review Division's and District Office's. Strong leadership skills that has helped retain and mentor people resulting in many positive outcomes for the company and individuals; as well as providing quality products to consumers.
Fidelis Animal Health, Inc.
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Svp Regulatory Affairs And QualityFidelis Animal Health, Inc.Rockaway, Nj, Us
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Svp Regulatory Affairs & QualityFidelis Animal Health, Inc. May 2021North Brunswick, Nj
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OwnerWitham Regulatory-Quality Consulting, Llc Mar 2016 - May 2021Witham Regulatory-Quality Consulting, LLC is not active while I am working full-time at Fidelis.
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Vp Regulatory Affairs, Quality Assurance, And Quality ControlKremers Urban Pharmaceuticals Inc. Jun 2013 - Mar 2016Princeton, NjI was responsible for approx. 230 employees within the QA, QC and RA departments. Responsible for ensuring quality and compliance within the manufacturing facility as well as ensuring that quality applications, supplements, amendments, and responses were submitted to FDA Review Divisions and District Offices. -
Own Consulting CompanyWitham Regulatory-Quality Consulting Llc Oct 2012 - Jun 2013Consulted for Compounding Pharmacies addressing FDA 483 observations. Also, helped other Pharma Companies with FDA 483 matters.
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Evp Regulatory Affairs And Quality AssuranceShionogi Inc Sep 2007 - Oct 2012Florham Park, NjEVP of RA and QA. Restructured the QA department and worked closely with the Atlanta FDA District Office. Team managed over 50 CMOs. Built a strong RA and QA department to manage FDA filings and cGMPs. -
Vp Regulatory AffairsAdams Respiratory Therapeutics, Inc. Oct 2004 - Nov 2006Chester, Nj
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Vp Regulatory AffairsColumbia Laboratories, Inc. Apr 2002 - Oct 2004Livingston, Nj
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Regulatory Affairs-Head Of Oncology, Metabolism, And Pulmonary Drugs/Marketed Products And PracticesAventis Pharmaceuticals Corp (Now Sanofi-Aventis) Sep 2000 - Apr 2002Bridgewater, Nj
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Regulatory Affairs-Director- Head Of Rx Dermatologic ProductsJohnson & Johnson Consumer Products Worldwide/Ortho Dermatological Drug Products Nov 1999 - Aug 2000
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Analytical Chemist/Compliance/Regulatory AffairsNovartis Pharmaceuticals 1983 - 1999While in RA, responsible for CNS products.
Susan Witham Skills
Susan Witham Education Details
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Biology
Frequently Asked Questions about Susan Witham
What company does Susan Witham work for?
Susan Witham works for Fidelis Animal Health, Inc.
What is Susan Witham's role at the current company?
Susan Witham's current role is SVP Regulatory Affairs and Quality.
What is Susan Witham's email address?
Susan Witham's email address is sw****@****ine.net
What schools did Susan Witham attend?
Susan Witham attended Bridgewater College.
What skills is Susan Witham known for?
Susan Witham has skills like Rx, Consulting, Regulatory Affairs.
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