Sebastian V. Joseph
Senior Director @PharmaLex
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WORK HISTORY
Senior Director @PharmaLex
New Delhi, IN
EDUCATION
Karnataka Veterinary University
M.V.Sc., Veterinary Pharmacology and Toxicology
University of Agricultural Sciences, Bangalore
D.V.M (B.V.Sc. & A.H.), Veterinary Sciences and Animal Husbandry
American Board of Toxicology
Diplomate of American Board of Toxicology, Toxicology
British society of toxicology
European Registered Toxicologist
SKILLS
ABOUT SEBASTIAN V. JOSEPH
Board certified toxicologist-pharmacologist with 14 years of experience in preclinical testing, pharmacology/safety pharmacology, experimental toxicology, occupational toxicology, drug discovery and development, toxicological risk assessment and regulatory toxicology, and assessment of cosmetic ingredients and products.Currently involved in strategic development and consulting services in pharmaceutical product development with special reference to toxicological requirements; non-clinical evaluation strategy in support of IND and NDA; risk assessment of pharmaceutical active ingredients and excipients; impurity qualification of APIs and drug products; risk assessment and derivation of permitted daily exposure (PDE) and occupational exposure limit in support of GMP manufacturing; environmental risk assessment of pharmaceuticals; review investigator\'s brochure, non-clinical and clinical overview of CTD modules; respond to regulatory queries as appropriate; toxicological risk assessment and safety evaluation of cosmetic ingredients/products, medical devices, consumer products and exposure assessment and DNEL derivation in support of REACH; lead, coach and mentor team of toxicologists and medical writers; refine and implement ISO 9001: 2015 standards, and implement quality standards towards achieving operational excellence.
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