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Alison T. personal email
Regulatory Affairs professional (RAC Drugs certified) with 11+ years of Regulatory Affairs experience and 15 years of industry experience, including regulatory affairs CMC biologics, regulatory strategy, and regulatory operations.
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Director, Regulatory Affairs Vaccines CmcTakeda Feb 2023 - PresentTokyo, Jp
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Manager, Regulatory AffairsParexel Jun 2022 - Feb 2023Durham, North Carolina, UsProviding RA CMC consulting services for vaccines and biologics, and RA strategy for oncology cell/gene therapy products.Managing a team of consultants within Parexel -
Senior Regulatory Affairs Consultant - CmcParexel Aug 2020 - May 2022Durham, North Carolina, UsProviding RA CMC consulting services for vaccines and biologics.
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Global Regulatory LeadSanofi Dec 2018 - Aug 2020Paris, France, Fr• Lead Global Regulatory Team for portfolios of ~45 marketed primary care products by actively contributing to the development and implementation of regulatory strategies and timelines• Interact with a cross-functional team in the collection, review and assembling of the scientific, clinical, manufacturing and administrative section documents for global submissions to regulatory authorities• Ensure the appropriate peer review of key regulatory documents and submissions across programs in the portfolio• Proactively identifies and communicates to higher management all potential risks and options for issue resolution (e.g. maintenance issues, submissions, etc.)• Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes• Ensure compliance with all internal and external requirements and procedures -
Regulatory Affairs Cmc Manager - Bacterial VaccinesSanofi Jun 2015 - Dec 2018Paris, France, FrGlobal Regulatory affairs CMC lead for a bacterial polysaccharide vaccine licensed in 68+ countriesResponsibilities included global strategy, dossier conformance, variation authoring, change control assessment, etc.
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Principal Regulatory AssociateEli Lilly And Company Dec 2012 - May 2015Indianapolis, Indiana, UsPrincipal Regulatory Associate accountable for the operational and technical IND & NDA/BLA registration management processes that support the expedited delivery of safe and effective products to patients; selected to serve as lead Regulatory Scientist/Liasion/Strategist for a small molecule, oncology drug project.Guide and influence development team and function regarding internal and Agency registration management processes and requirements.Serve as the Global Regulatory Affairs US (GRA-US) operational lead for IND and NDA registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and GRA planning.Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER), routine maintenance submissions, tracking the status of pending applications and commitments, incoming correspondence and records of contact, assisting in CMC (Chemistry, manufacturing and controls) for biologics. Orphan Drug application submission and Orphan Drug Annual Progress report authoring and filing.Serve as a mentor within GRA.Authoring and owning the Target Product Profile (TPP) for marketed and pre-clinical compounds.eCTDXpress cloning experience.Japanese submissions SME - work with Japanese affiliates to optimize submission process between US-based regulatory team and Japanese affiliates for quality, timely submissions. -
Process Development Cell Culture AssociateEli Lilly And Company May 2009 - Dec 2012Indianapolis, Indiana, UsMaintain suspension (CHO, NS0) and adhesion cell lines using cell culture.Cell cultivation and production in Erlenmeyer flasks, 3L Bioreactors, T-Flasks, and roller bottles.Execute and write official study and validation protocols and reports to justify changes in commercial manufacturing. Conduct manual and Vicell® cell counting, and measure pH, blood gases, and osmolality.United Way steering committee member. Manage and assist accordingly for United Way events on ImClone campus.Operate and maintain NOVA® Bioprofile 100, 400, and ABL5Train incoming coworkers and interns on lab activities and SOPS.Execute experiments involving optimizing media and increasing cell line productivity.Follow and write SOPs.Collect data in laboratory notebooks using GLP/GMP guidelines.Conduct 3L, 15L, 60L and 300L bioreactor operations.Maintain laboratory and inventory.Work with vendors to order optimal parts for 3L Applikon assemblies and lab.Perform autoclaving and washroom activities.
Alison T. Skills
Alison T. Education Details
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Seton Hall UniversityBiology -
University Of Southern CaliforniaManagement Of Drug Development
Frequently Asked Questions about Alison T.
What company does Alison T. work for?
Alison T. works for Takeda
What is Alison T.'s role at the current company?
Alison T.'s current role is Global Regulatory Affairs CMC vaccines and biologics.
What is Alison T.'s email address?
Alison T.'s email address is al****@****ofi.com
What schools did Alison T. attend?
Alison T. attended Seton Hall University, University Of Southern California.
What are some of Alison T.'s interests?
Alison T. has interest in Children, Economic Empowerment, Civil Rights And Social Action, Education, Poverty Alleviation, Science And Technology, Human Rights, Animal Welfare.
What skills is Alison T. known for?
Alison T. has skills like Cell Culture, Validation, Gmp, Laboratory, Cell, Cgmp, Process Development, Process Simulation, Bioreactors, Technical Documentation, Process Manufacturing, Process Optimization.
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