Manager-Biologics Regulatory Affairs (Clinical Trials)

You will be responsible for the following key activities in the role of Asst Manager / Manager - Regulatory Affairs (Clinical Trials) for EU and US markets at USV Private Limited: Role Overview: You will be part of the Biologics function at USV Private Limited and will focus on Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets. Key Responsibilities: - Develop Biosimilar Clinical design and Protocol for EU and US markets. - Manage Biosimilar Clinical Trial Application, including the overview of clinical study conduct and finalization of Clinical Study reports for EU and US markets. - Author and review Biologics/Biosimilar Dossiers, and handle eCTD submissions for EU and US markets. - Respond to Ministry of Health (MOH) queries. - Support Product Life Cycle Management. - Provide Regulatory Affairs (RA) support for Plant related Quality Management System (QMS) activities. Qualifications Required: - M.Pharm/B.Pharm degree - 5-15 years of experience in RA-Clinical Trials for EU and US markets About USV Private Limited: USV Private Limited is a top-15 pharmaceutical company in India, specializing in the diabetes and cardio sectors. The company has a global presence in over 65 countries. The job location for this position is in Govandi (East), Mumbai, with a work schedule of 1st, 3rd, 5th Saturdays working, and 2nd and 4th Saturdays off.,