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Sonam Jain

Regulatory Toxicologist- Looking for new opportunity in Delhi NCR

New Delhi, India

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.
Key skills:
- Pre-clinical, clinical trial data and study reporting
- Basic of IND, NDA, ANDA, ASMF submissions, CTD etc.
- Pharmaceutical subjects, ICH guidelines etc.

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Experiences

Research associate

Evalueserve  |  India

November, 2012 - April, 2014 (1 Year 5 Months)

Executive Regulatory Toxicologist
Dynamic Orbits Advisory Pvt. Ltd.
August 2012 – November 2012

Regulatory Toxicology

National Institute of Pharmaceutical Education and Research  |  Mohali, India

July, 2010 - June, 2012 (1 Year 11 Months)

Inhalation toxicity study of ZnO nano-particle co-exposed with toluene through Nose-only exposure assembly of CH technology.

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 Education

...

M.S.(Pharm.)-Regulatory Toxicology, 9.28

NIPER, Mohali-India

India

2010 - 2012 (2 year)

...

B. Pharm--

Shri Govindram Sakseria Institute of Technology an-India

India

2006 - 2010 (4 year)

...

Higher secondary--

Madhya Pradesh higher secondary board-India

India

2005 - 2006 (1 year)

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