Anshi Soni

Background

About Anshi Soni

Regulatory Affairs professionals with 17 years of vast experience in leading roles in Regulatory Affairs and compliance over diversified categories and varied geographies. Hands on experience in handling the regulatory governance and compliance activities for Chocolates, Gum Mints and Fruity confections, Alcoholic beverages category like Whisky, Vodka, Scotch, ready to drink beverages, carbonated drinks for India Region. Worked with Industrial Associations like CII, FICCI for policy change matters. Lead the representations to the scientific committee. Headed the entire portfolio of health supplements/ nutraceuticals and consumer health care segment products including OTC category. Vast exposure in recipe compliance, artwork text creation, strategizing claims and promotional materials, regulatory support for food product development, work on policy change matters with industry associations to make organization future ready. Provides strategic advice to senior management on regulatory requirements throughout development/approval and post approval activities. Extensive understanding of the procedures of food and drug registration with FSSAI and DCGI in India. Experience in review of data required for claims rationalization, responding to deficiencies raised by Legal Metrology, ASCI, Drug and Food inspectors in coalition with legal teams. Led R&D digitization/modernizarion projects. Also worked with Pharmaceutical Industry and has thorough knowledge of all regulations of ICH, EMA and regulations for India. Handling changes pre and post approval of regulatory submissions for European Market.Experience in project management from inception to development including complete life cycle management.