Elize Varghese

Key contributor to IVDR 2017/746 transition of class D Immunoassay diagnostic products, and support to the transition of Class B and C clinical chemistry products. Continuing support to on market product life cycle activities and site operational support. This role has given me deep expertise on Notified Body regulatory submissions and approvals, technical documentation and conformity assessment, risk classification, safety and quality standards, database maintenance and project management skills.

Handled projects in life sciences and coordinated efforts with the digital products and solutions team. Life sciences industry analysis- worked with key accounts teams like Pfizer, Merck, and Novartis tracking new product developments, regulatory changes, market potential, growth strategies. Supported deployment, user based testing and operational functioning of a market expansion product suite. Analyzed trends and market expansion strategies in life sciences and pharma industry

Drugs and biologics regulations, regulatory agencies (FDA & EMA) and their approval pathways, fundamentals of clinical trials, GXPs, ICH guidelines, CTD submission, dossier preparation and global regulatory affairs.

Molecular Biology, Immunology, Biochemistry, Protein Engineering Published a research article in the field of Molecular biology: phytochemical, antioxidant and nutrient analysis of medicinal rice (Oryza Sativa L.) varieties found in South India; Vol. 5, 1-5, 2012