S. Sianna Castillo Email and Phone Number
S. Sianna Castillo work email
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S. Sianna Castillo personal email
Experienced Regulatory Affairs CMC professional with experience in developing complex regulatory strategies and executing plans for clinical trial applications, new marketing applications and post-approval variations. Over 16 years experience of working in the biotechnology industry in the rare disease/orphan drug space.
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Senior Director Of Regulatory Affairs, CmcUltragenyxNovato, Ca, Us
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Senior Director Of Regulatory Affairs, CmcUltragenyx Jun 2024 - PresentNovato, California, Us -
Senior DirectorSangamo Therapeutics, Inc. Sep 2021 - May 2024Brisbane, California, Us•Responsible for developing innovative CMC regulatory strategies for multiple in vivo and ex vivo cellular gene therapy and gene editing products to transform the lives of patients with serious diseases.•Responsible for leading CMC regulatory interactions with health authorities including the preparation of briefing packages, conduct of the meeting and documentation of meetings.•Ensure adherence to CMC regulatory guidelines relevant for the development of in vivo and ex vivo cellular gene therapy and gene editing products.•Support negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators; support interactions with regulatory agencies during inspections.•Responsible for coaching, mentoring, and developing an effective CMC Regulatory team. -
Director Of Regulatory Affairs, Cmc Group At Biomarin Pharmaceutical, IncBiomarin Pharmaceutical Inc. Sep 2018 - Sep 2021San Rafael, Ca, Us -
Associate Director-Regulatory Affairs, CmcBiomarin Pharmaceutical Inc. Feb 2012 - Sep 2021San Rafael, Ca, UsResponsible for the coordination and preparation of CMC-related content for biological and combination product regulatory submissions (domestic and APAC regions) working closely with Regulatory International and Technical Operations.
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Scientist IiBiomarin Pharmaceutical Inc. 2007 - 2012San Rafael, Ca, UsDeveloped bioanalytical assays to support pharmacokinetic, anti-drug antibody and biomarker analysis to support non-clinical and clinical studies.
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Post-Doctoral ScholarUc Davis Feb 2004 - May 2007Davis, California, UsStudied the regulation of neutral and acidic sphingomyelinase enzymes by tobacco-smoke related compounds such as reactive oxygen and reactive nitrogen species. -
Post-Doctoral FellowNih 2000 - 2004Bethesda, Md, UsStudied the Akt signaling pathway in lung and breast cancer cells and evaluated early stage inhibitors to the Akt pathway as potential novel chemotherapeutic agents.
S. Sianna Castillo Skills
S. Sianna Castillo Education Details
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Purdue UniversityBiochemical And Molecular Nutrition -
University Of KentuckyBiochemical Nutrition
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University Of California, BerkeleyNutrition And Food Science
Frequently Asked Questions about S. Sianna Castillo
What company does S. Sianna Castillo work for?
S. Sianna Castillo works for Ultragenyx
What is S. Sianna Castillo's role at the current company?
S. Sianna Castillo's current role is Senior Director of Regulatory Affairs, CMC.
What is S. Sianna Castillo's email address?
S. Sianna Castillo's email address is sc****@****mrn.com
What schools did S. Sianna Castillo attend?
S. Sianna Castillo attended Purdue University, University Of Kentucky, University Of California, Berkeley.
What skills is S. Sianna Castillo known for?
S. Sianna Castillo has skills like Assay Development, Biotechnology, Regulatory Submissions, Cell, Biomarkers, Pharmaceutical Industry, Bioanalysis, Life Sciences, Fda, Antibodies, Glp, Drug Discovery.
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