Mary Wilhelm Email and Phone Number
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Mary Wilhelm personal email
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Regulatory affairs professional with extensive experience in clinical and post approval drug development activities. Includes EU MAA and US BLA approvals and successful Advisory Committee meeting preparations. Strengths include developing regulatory intelligence and strategy, preparing regulatory submissions, and interacting with domestic and international regulatory agencies. Experienced in preparing teams for regulatory agency meetings, managing interface with agencies and certifying bodies for site inspections, organizing regulatory agency meetings and preparing submissions. Proven expertise in developing, applying, and maintaining a compliant quality system per FDA and ISO requirements. Demonstrated communications, interpersonal, and leadership skills. Mentors and develops other regulatory professionals.
Ascendis Pharma
View- Website:
- ascendispharma.com
- Employees:
- 1192
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Senior Director Regulatory AffairsAscendis PharmaSan Diego, Ca, Us
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Head, Regulatory Policy And IntelligenceAscendis PharmaSan Diego, Ca, Us
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Guest LecturerUniversity Of Southern CaliforniaSan Diego, Ca, Us -
Guest LecturerUniversity Of Southern California Jun 2023 - PresentLos Angeles, Ca, Us
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Senior Director Regulatory AffairsAscendis Pharma Sep 2021 - PresentHellerup, Capital Region Of Denmark, Dk
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Adjunct FacultySan Diego State University Aug 2005 - May 2022San Diego, Ca, Us -
Executive Director, Regulatory Affairs, R&DIntercept Pharmaceuticals Sep 2019 - Sep 2021Morristown, New Jersey, Us -
Senior Director, Regulatory AffairsHalozyme Therapeutics, Inc. Sep 2015 - Sep 2019San Diego, California, UsHead for regulatory team that supports alliance partnerships and internal programs. Provides leadership in interactions with Research & Development, Product Development and Clinical Development to ensure an effective linkage of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. -
Director, Regulatory AffairsHalozyme Therapeutics, Inc. Jul 2012 - Sep 2015San Diego, California, Us
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Associate Director, Regulatory Affairs & Quality AssuranceHalozyme Therapeutics, Inc. Oct 2006 - Jul 2012San Diego, California, Us
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Senior Manager, Regulatory Affairs & Quality AssuranceHalozyme Therapeutics, Inc. Apr 2005 - Oct 2006San Diego, California, Us
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Regulatory Affairs ManagerCp Kelco 1999 - 2005Atlanta, Georgia, Us -
Quality Assurance SpecialistMonsanto 1997 - 1999St. Louis, Missouri, Us
Mary Wilhelm Skills
Mary Wilhelm Education Details
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University Of Southern CaliforniaRegulatory Sciences -
San Diego State UniversityRegulatory Affairs
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Purdue UniversityChemistry
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Purdue UniversityChemistry
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Purdue UniversityTextile Science
Frequently Asked Questions about Mary Wilhelm
What company does Mary Wilhelm work for?
Mary Wilhelm works for Ascendis Pharma
What is Mary Wilhelm's role at the current company?
Mary Wilhelm's current role is Senior Director Regulatory Affairs.
What is Mary Wilhelm's email address?
Mary Wilhelm's email address is mw****@****yme.com
What is Mary Wilhelm's direct phone number?
Mary Wilhelm's direct phone number is (858)-794*****
What schools did Mary Wilhelm attend?
Mary Wilhelm attended University Of Southern California, San Diego State University, Purdue University, Purdue University, Purdue University.
What skills is Mary Wilhelm known for?
Mary Wilhelm has skills like Regulatory Affairs, Fda, Regulatory Submissions, Drug Development, Biotechnology, Quality Assurance, Clinical Research, Ind, Pharmaceutical Industry, Quality System, Life Sciences, Gmp.
Who are Mary Wilhelm's colleagues?
Mary Wilhelm's colleagues are Mike Dewitt, Sofie Mathilde Brøgger, Line Benzin, Manuela Arbelaez, Yan Liu, Layla Neuman, My Lund.
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