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Elizabeth Williams is a Vice President, Regulatory Affairs and Head of Regulatory Operations at Apogee Therapeutics. She possess expertise in biotechnology, regulatory affairs, regulatory submissions, pharmaceutical industry, fda and 5 more skills.
Apogee Therapeutics
View- Website:
- apogeetherapeutics.com
- Employees:
- 245
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Vice President, Regulatory Affairs And Head Of Regulatory OperationsApogee TherapeuticsUnited States
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Executive Director Regulatory AffairsApogee Therapeutics Feb 2024 - PresentFully Remote, Us, UsGlobal Regulatory Lead developing and implementing regulatory strategies within the Respiratory therapeutic area to deliver on Company goals. Develop processes to ensure Regulatory compliance. Head of Regulatory Operations.
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Senior Director Regulatory AffairsAcelyrin, Inc. Mar 2022 - Feb 2024Agoura Hills, California, UsDevelop and implement global regulatory strategies within the General Medicine therapeutic area (dermatology, rheumatology, ophthalmology) to deliver on Company goals. Lead the Regulatory team and develop processes to ensure Regulatory compliance. -
Director Global Regulatory AffairsAmgen Jul 2021 - Mar 2022Thousand Oaks, Ca, UsLead Global Regulatory Teams for early stage, late stage and marketed products within the General Medicine therapeutic area. Work with global, regional and local teams to develop and implement regulatory strategy, to deliver on the Product Team goals. -
Director International Regulatory AffairsAmgen Nov 2020 - Jul 2021Thousand Oaks, Ca, UsRegional Group Lead for the General Medicine and Biosimilars portfolio covering Canada, Latin America, Turkey, Middle East and Africa. Manage a team of Regulatory professionals. Liason between the global and local teams for early/late stage and marketed products. Lead cross-functional teams. Provide regulatory guidance to teams. Review promotional/non-promotional material. Manage Regulatory budget.
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Senior Manager International Regulatory AffairsAmgen Jul 2016 - Nov 2020Thousand Oaks, Ca, UsRegulatory Lead covering Canada, Latin America, Turkey, Middle East and Africa. Liason between the global and local teams for early/late stage and marketed products. Manage regulatory submissions. Lead cross-functional teams. Provide regulatory guidance to teams. Business Process Owner (BPO) of global labeling process, including labeling system development, implementation and process/SOP development.
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Global Labeling LeadAmgen Nov 2013 - Jul 2016Thousand Oaks, Ca, UsGlobal Labeling Lead - November 2013 to October 2014: Facilitated development and updates to Company Core Data Sheets, US and EU prescribing information for marketed and non-marketed products.Regional Labeling Lead (Latin America) - October 2014 to July 2016: Facilitated development of initial and updates to prescribing information across all South American coutries for all Amgen products.
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Manager Regulatory AffairsAmgen Feb 2009 - Nov 2013Thousand Oaks, Ca, UsUS Regulatory Lead: Primary FDA contact for early/late stage and marketed products. Manage regulatory submissions. Lead cross-functional teams. Facilitate FDA meetings. Provide US regulatory guidance to teams.
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Associate ScientistAmgen Nov 2005 - Feb 2009Thousand Oaks, Ca, UsLC-MS/MS bioanalysis for small molecules.
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ScientistGlaxosmithkline Feb 2004 - Mar 2005Brentford, Middlesex, GbLC-MS/MS bioanalysis for small molecules. -
Research Associate IiAmgen Feb 2001 - Feb 2004Thousand Oaks, Ca, UsLC-MS/MS bioanalysis for small molecules.
Elizabeth Williams Skills
Elizabeth Williams Education Details
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University Of Southern CaliforniaRegulatory Science -
Loyola Marymount UniversityNatural Sciences
Frequently Asked Questions about Elizabeth Williams
What company does Elizabeth Williams work for?
Elizabeth Williams works for Apogee Therapeutics
What is Elizabeth Williams's role at the current company?
Elizabeth Williams's current role is Vice President, Regulatory Affairs and Head of Regulatory Operations.
What is Elizabeth Williams's email address?
Elizabeth Williams's email address is st****@****ail.com
What is Elizabeth Williams's direct phone number?
Elizabeth Williams's direct phone number is +180544*****
What schools did Elizabeth Williams attend?
Elizabeth Williams attended University Of Southern California, Loyola Marymount University.
What skills is Elizabeth Williams known for?
Elizabeth Williams has skills like Biotechnology, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Fda, Biopharmaceuticals, Drug Development, Ind, Gcp, Small Molecules.
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