Few assignments included- - Development and qualification of a novel excipient.- Development of a few dietary supplements for the global market.

Worked as a Research Scientist (Regulatory Affairs) in Sun Pharm Industries Ltd (erstwhile Ranbaxy) at Gurgaon from June 2013. Here I was providing regulatory support in different projects for different markets, like:1. Filing of NDA (a fixed dose combination of a new chemical entity) in India, different countries of Africa (FWA/RoA) and MENA regions. Post approval activities include filing of variation dossiers related to quality part and Life cycle management of the approved… Show more Worked as a Research Scientist (Regulatory Affairs) in Sun Pharm Industries Ltd (erstwhile Ranbaxy) at Gurgaon from June 2013. Here I was providing regulatory support in different projects for different markets, like:1. Filing of NDA (a fixed dose combination of a new chemical entity) in India, different countries of Africa (FWA/RoA) and MENA regions. Post approval activities include filing of variation dossiers related to quality part and Life cycle management of the approved product.2. Development of products (505 b 2 applications) in compliance with USFDA guidelines. It included an Oral Chronotherapeutics Antidiabetic and a parental product (Pen device) containing Peptide.3. Successfully applied for ATC (Anatomical Therapeutic Classification) code to WHO.4. Participated in obtaining scientific advice procedure from EMA for our NDA and Pediatric investigation plans. Show less

1. Provided regulatory inputs in the development of NCEs, NDAs and Differentiated Products in compliance with all applicable country specific guidelines.2. Prepared of regulatory dossiers for IND and NDA fillings for NCEs and New Drug products.3. Supported R&D teams in developing Biosimilar products and Combination products (Medical devices).