Metina PharmConsulting

The person will be responsible for project specific regulatory consulting services at the firm. You will have complete ownership of all regulatory projects, including dossier writing, submissions, approval tracking, and query resolution across Developed and Emerging markets. Your role will involve ensuring regulatory compliance, accuracy, timely completion, version control, and adherence to internal SOPs. Additionally, you will provide strategic input to the Management and Partners on regulatory projects. It is essential to keep abreast of new developments in regulations across all critical health authorities. The ideal candidate should have formal regulatory affairs experience for a minimum of 8 years. Experience with a consulting company and a previous managerial role would be considered an advantage. Specific experience with 505(b)(2) and 505(j) ANDA writing, ANDS submissions and approvals, as well as experience in using eCTD software for publication is required. Experience in DCP filing and m1-m5 CTD writing for EU, Australia, Canada is also preferred. Proficiency in computer and technical skills, including eCTD software knowledge, is necessary. Strong and flawless communication skills are essential for this role, along with a high level of accuracy and attention to detail. This position is located in Navi Mumbai.,