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25 years in pharmaceutical/biotechnology regulatory affairs• Liaison with health authorities; regulatory strategy; project manager with hands-on role for preparation of submissions• Regulatory generalist (clinical, nonclinical, CMC, labeling, publishing) with experience across different therapeutic areas and dosage forms• Early- and late-stage development, including investigational and marketing applications (pre-IND and IND/CTA phases, NDA/BLA/MAA filings through approval) and post-marketing expertise• Regulatory research/intelligence for special assignments and due diligence support• Built regulatory function in small-company environments; hiring manager and supervisor for permanent and contractor/CRO staff• Fiscal responsibility for departmental budgeting, forecasting and invoice approvals
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Sr Vice President, Regulatory AffairsIncarda Therapeutics May 2018 - Mar 2021Newark, Ca -
Vice President, Regulatory Affairs And QualityBioinspire Technologies Inc. Mar 2016 - May 2018Palo Alto, Ca
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Sr Vice President, Regulatory AffairsCellerant Therapeutics Oct 2010 - Mar 2016San Carlos, Ca -
Regulatory AffairsGilead Sciences Jun 2009 - Jan 2010 -
Vice President Regulatory AffairsCv Therapeutics Aug 2000 - Jun 2009 -
Director Regulatory AffairsSystemix (Novartis) May 1998 - Jul 2000
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Director Regulatory AffairsConnetics Apr 1996 - Apr 1998 -
Associate Director Regulatory AffairsSchering-Plough Pharmaceuticals Mar 1991 - Mar 1996 -
Postdoctoral Fellow/Research ScientistVarious Universities And Companies Sep 1982 - Oct 1989
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Frequently Asked Questions about Margaret Dillon
What is Margaret Dillon's role at the current company?
Margaret Dillon's current role is Retired.
What is Margaret Dillon's email address?
Margaret Dillon's email address is ma****@****ics.com
What is Margaret Dillon's direct phone number?
Margaret Dillon's direct phone number is +165023*****
What schools did Margaret Dillon attend?
Margaret Dillon attended State University Of New York At Buffalo - School Of Pharmacy And Pharmaceutical Sciences, University At Albany, Suny.
What skills is Margaret Dillon known for?
Margaret Dillon has skills like Generalist, Regulatory, Labeling, Biotechnology, Regulatory Affairs, San.
Not the Margaret Dillon you were looking for?
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Margaret Dillon
Board Member At Guidewire Software, Hi Marley And White Mountains Insurance GroupNorfolk, Ma2libertymutual.com, guidewire.com2 +178189XXXXX
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Margaret Dillon
Naperville, Il2 +154033XXXXX
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1wustl.edu
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