Nishant Singh

Experience

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  Auriga Research Private Ltd.

  Apr 2010 - Apr 2011

  Clinical Research Coordinator

  1. Involved in the activities related with BA/BE Studies like,Subject Admission, Enrollment and Registration Process,Screening Process.2. Quality Control Activities, Data Management And Protocol Development Process.3. Maintenance of Source documents, Investigator Site File, Essential documents and other study documents.4. Assists the Senior Clinical Research Coordinator in receipt and accountability of investigational product.5. Face internal quality audits6. Preparing clinical study reports.7. To establish and maintain effective cordial workingrelationships with colleagues, managers and internal aswell as external clients.8. Communication with Ethics Committee. Show less

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  Nestor Pharmaceuticals Limited

  Apr 2011 - Apr 2012

  Drug Regulatory Affairs

  MAKE DOSSIERS FOR THE FOLLOWING COUNTRIES:1) AFRICAN COUNTRIES( Kenya, Ethopia,Congo,Tanzania, Nigeria, Sudan,Ivory Coast, South Africa)2) SOUTH EAST ASIA (Vietnam, philippines, Laos, Thailand, Malayasia)3) SOUTH AMERICA ( Chile,Colambia,Peru,Guyana)4)Indian SubContinents (Srilanka,Mayanmar, Bangaladesh)5)North America ( Honduras, Guatemala, Costa Rica, EL Salvador, Nicargua, Panama)• Responding queries received from various regulatory authorities.• Coordinating with the Bioequivalence Study Investigator and CRC.• Initiation of documents for getting the COPP and licensing documents for Product approval.• Review of documents like Master & Executed Batch Production Record & all kinds of Specifications for various regulatory submissions.• Collecting documents from quality assurance department, reviewing & forwarding to different regulatory authorities in the form of Dossiers.• Coordinating with supportive functions via, regulatory authorities & R&D for smooth & timely regulatory submissions. Show less

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  Auriga Research Private Ltd.

  Apr 2012 - Sept 2015

  Clinical and Drug Regulatory affairs

  I. Business Generation & DevelopmentII. Clinical Operations:1. Clinical Trials(PhI-IV):Project Management2. Medical Writing: Clinical Trials (Phase-I-IV), Medicoregulatory (e-CTD Modules 2,4&5) and Medicomarketing3. Regulatory Support: Indian (CDSCO) & International4. Research and development: Formulation Development, Stability studies, Biowaivers, dissolution5. Food and Nutraceuticals registration FSSAI.

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  Sanat Products Limited

  Sept 2015 - Oct 2017

  Regulatory Affairs

  ➢Clinical Trials Project Management for Nutraceutical products.➢Medical Writing: Protocol Writing, Report writing ➢New Product development for herbal extracts➢Regulatory Support: FSSAI Licensing central and state , Indian (CDSCO) & International➢Dossier writing ➢Research and development: Stability studies, Biowaivers, dissolution➢Product registration for Formulations and Herbal extracts like Curcumin, Garcinia, Centella, Bacopa, Spirulina etc.

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  Bath & Body Works

  Oct 2017 - Feb 2019

  Regulatory Compliance Manager

  Doing Import registration in CDSCO for International Brands- Bath and Body Works, La Senza U.S (Victoria secrets Beauty). ➢ Responsible for Regulatory compliance of Cosmetics as per D&C Act at CDSCO (India). ➢ Handling product registration in categories like Body care, Hair care, Soaps, Hydro Alcoholic Perfumes, Mechanical exfoliation, Bath/Shower Product, Other skin cleansing products, Eye shadow, Foundation, Other face make up, Mascara, Lipstick, Nail varnish/Nail make-up and Other lip make-up products. ➢ Handling and resolving Regulatory queries by authorities. ➢ Handling Legal and Admin documents required for registration. ➢ Taking care of amendments and current guidance on regulatory and stay in contact with regulatory people in Govt. Department. Show less

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  INGLOT COSMETICS

  Oct 2017 - Feb 2019

  Manager Regulatory and compliance

  ➢Doing Import registration in CDSCO for International Brand- INGLOT (Poland). ➢ Responsible for Regulatory compliance of Cosmetics as per D&C Act at CDSCO (India). ➢ Handling product registration in categories like Body care, Hair care, Soaps, Hydro Alcoholic Perfumes, Mechanical exfoliation, Bath/Shower Product, Other skin cleansing products, Eye shadow, Foundation, Other face make up, Mascara, Lipstick, Nail varnish/Nail make-up and Other lip make-up products. ➢ Handling and resolving Regulatory queries by authorities. ➢ Handling Legal and Admin documents required for registration. ➢ Taking care of amendments and current guidance on regulatory and stay in contact with regulatory people in Govt. Department. Show less

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  Forest Essentials

  Feb 2019 - Nov 2022

  Regulatory Affairs Manager

  ➢Responsible for making PIF (Product information file) as per EU Regulation 1223/2009 for Existing and New products for export registration in European Union. ➢ Responsible for making product dossier for US as per FDA cosmetic guidance. ➢ Responsible for doing Import registration with CDSCO.➢ Taking care of amendments and current guidance on regulatory and stay in contact with regulatory people in Govt. Department. Give internal training for same. ➢ Development of PIL (Product information leaflet) as per country regulatory guideline and International standards. ➢ Label review as per D&C act and Legal Metrology act.➢ Product’s ingredients screening – Check and guide to team about changes in ingredients regulations, accepted limits, banned ingredients etc. ➢ Check product’s claim and supporting data according to export regulations.➢ Handle projects which are related to product certifications like Ecocert, USDA, Cosmos, USOCA, IFRA, Organic certifications. ➢ Monitoring and Execution of Clinical Studies for cosmetic claims such as Anti wrinkle, Skin whitening, Hair growth, Dark circles, Patch testing, SPF Claims etc. ➢ Cosmetic manufacturing Licensing and Product licensing from State drug authority.➢ Approved Manufacturing Chemist for Cream, Lotion, Oil, Shampoo, Perfume, Lipsticks, Kajal & Soap. Show less

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  Freyr Solutions

  Nov 2022 - now

  Manager Global Regulatory Intelligence

  · Subject Matter Expert on Cosmetic Safety and Regulatory Compliance in global markets· Responsible for preparing and implementing global strategic regulatory plan for cosmetics, consumer goods and chemicals.· Stay abreast of current / new regulations and guidelines, record and shares changes / updates to ensure adherence throughout product life cycle.· Design, implementation, and maintenance of global regulatory databases for cosmetics and chemicals covering prohibited / restricted substances and pertinent regulatory obligations. · Proactive regulatory observance and monitoring of regulatory and scientific developments with potential to amend regulatory status of cosmetic ingredients and chemicals. · Carry-out regulatory review and compliance, gap assessment for Product stewardship.· Attend to technical queries on global regulations, recent updates, product safety and compliance. · Co-ordinate with Product engineering team and modify data structure and formats for presentation in digital dashboard. Show less