Claire Friry-Santini
Global Regulatory Toxicologist - Human Safety - Regulatory Sciences @Bayer
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WORK HISTORY
Global Regulatory Toxicologist - Human Safety - Regulatory Sciences @Bayer
Global responsibility within Regulatory Toxicology for assigned Active Substances (e.g. completeness and quality of data, end point determination, state of the art Human health assessments).Provides toxicology support on Active Substances and Products registration/re registration worldwide- ensure alignment and communication of toxicology strategies and activities across all regions (APAC, NA, LATAM, EMEA)- participate as the expert representative in interdisciplinary projects and be accountable for the regulatory toxicology strategy in the context of achieving and maintaining registrations- compile necessary documents and write dossiers; develop position papers, and develop testing strategies as needed to fulfill regulatory requests- ensure that all studies required for global registration / re registration are initiated on time and meet all requirements of relevant regulatory authorities. Where relevant, act as Study Monitor and provide GLP compliant reports- provide planning, scheduling and cost estimates to global regulatory or project managers for all function relevant studies and track their progress; solicit input from regulatory toxicologists in the regions as appropriate; and track study progress, keeping regions informed of any issues and results- coordinate and provide input into exposure and / or risk assessments- collaborate with external consultants, academia, regulators and CROs- interact with Scientific Organisations, Industry Associations (CLE/CLI)
EDUCATION
Project Management Institute
Project Manager Professional certificated, Project Management
Ecole nationale vétérinaire de Lyon
Niveau 1 (concepteur) Experimentation Animal
Université Côte d'Azur
Master 2 Research, Pharmacology, Cell Biology and Molecular Biology
Université Claude Bernard Lyon 1
Initiation à la Pharmacocinetique
Université Claude Bernard Lyon 1
PhD Sciences/Heath, Toxicogenomic/Endocrine disruptors
Université Paul Sabatier Toulouse III
Master 2 Pro, Genic Expression and recombinant proteins
University of Surrey
CPD modules in Applied Toxicology , Carcinogenesis and Mutagenicity
SKILLS
ABOUT CLAIRE FRIRY-SANTINI
Toxicologist (ERT)| Biochemist by training | PhD Graduate in Sciences/Heath | PMP certified.With over 20 years of experience in both the Agrochemical and Pharmaceutical industries, and 3 years in Contract Research Organizations (CRO), I specialize in Regulatory Toxicology, Nonclinical Development, and Human Safety.Claire began her career at Bayer CropScience in 2002, focusing on Research Toxicology while completing her PhD. In 2008, she transitioned to Galderma R&D/Nestlé Skin Health as a Study Director & Study Monitor in pre-clinical, where she oversaw regulatory toxicology/Safety studies (non-GLP/GLP, in-/out-sourced). She also served as a Pre-clinical Project Manager for early projects, coordinating pre-clinical activities required for the development of New Chemical Entities (NCEs). In 2018, Claire joined the Translational Science department in Early Phase, Clinical Solution, within Syneos Health. She led a team of toxicology experts, ensuring the role of Pre-clinical Development Expert. Claire provided customers with pre-clinical strategies and development plans for drug candidate selection (NCEs, mAbs, MDs), and strategy of internal/outsourced activities as non-clinical prerequisites for human testing. Thanks to her skills and quality mindset, she developed and oversaw the Operational Quality Manager in charge of maintaining the Quality Management System (QMS) and acted as back-up of Test Facility Manager (GxP activities). In April 2022, Claire came back to Bayer CropScience as Global Regulatory Toxicologist, where she is in charge of Active Substances (3) and Products registration/re registration worlwide, ensuring effective communication and alignment of regulatory toxicology strategies and work programs across all regions. Claire is also an active member of CLE (TSG IVIVE) and member of HESI DART.Core Competencies:Management of Safety/Toxicology studies (regulatory package, rodents/non-rodents; in-/out-sourced activities, transversal management)Regulatory Toxicology strategy in Drugs/Plant Protection Products developmentProject Management (multidisciplinary projects, cross-functional coordination), Operational Quality & Quality Management System (GLP/GCLP),Fields of expertise: DART, EDsSoft skills: Claire is known for her open-mindedness, adaptability, and flexibility. She is committed to delivering high-quality work while respecting processes, costs, and timelines. A client-oriented professional with strong communication, analytical, and organizational skills, she is a team player who embodies strong ethics and leadership.
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