I am a passionate, motivated postgraduate in Regulatory Toxicology from NIPER, S. A. S. Nagar (Mohali). As a result of my education and more than two years of work experience, I have developed robust scientific knowledge and analytical skills that help me in toxicological data assessments in chemical, pharmaceutical and personal care product regulatory affairs-
1) Performing secondary searches for data collection via different databases like ECHA-Chem, CIR, eChemPortal, TOXNET, EFSA, INCHEM, EPA, FAO, HSDB, CDPR, Health Canada, EC, EXTOXNET, ECHA-C&L, APVMA, EPA etc.
2) Conduct literature searches and prepare toxicological assessment of various raw material/ingredients used in cosmetics and OTC products.
3) Preparation of dossiers (RSS in IUCLID) for the chemicals and regulatory submission of toxicity data to European Chemical Agency (ECHA). Risk and hazard assessment of chemicals for European countries.
3) Creation of Toxicological Profile for Personal Care Product ingredients.
4) Creation of Raw Material Tox-Profile for cosmetic ingredient as well as residual chemicals.
5) Conduct risk assessment for raw materials for cosmetic applications including margin of safety and California Prop 65 assessments.
6) Safety assessments of critical botanical extract (with low toxicity data) with application of TTC (threshold of toxicological concern), DST (dermal sensitization threshold) approaches
7) Drafting Cosmetic Product Safety Report (CPSR) and PIF [Product Information File] for cosmetic products as per EU cosmetic regulation.
8) Cosmetic or OTC Formulation evaluation other than EU regions based on MoS calculation
9) Summarized and detailed CCDS preparation (Toxicological section).
10) Flavor qualification for OTC products and oral care products.
11) PDE (Permitted daily exposure) calculations.
- Pre-clinical, clinical trial data and study reporting
- Basic of IND, NDA, ANDA, ASMF submissions, CTD etc.
- Pharmaceutical subjects, ICH guidelines etc.
2010 - 2012 (2 year)
Shri Govindram Sakseria Institute of Technology an-India
2006 - 2010 (4 year)
Madhya Pradesh higher secondary board-India
2005 - 2006 (1 year)
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