Biologics Regulatory Affairs Manager USV PRIVATE LIMITED

5.0 - 15.0 years

0 Lacs

maharashtra

On-site

You will be joining USV Private Limited, a leading pharmaceutical company in India known for its expertise in the diabetes and cardio sectors, with a global presence in over 65 countries. Your role will be in the Biologics function, specifically as an Assistant Manager or Manager in Regulatory Affairs (Clinical Trials) focusing on the EU and US markets. You will be based in Govandi (East), Mumbai, with a work schedule that includes working on the 1st, 3rd, and 5th Saturdays, while having the 2nd and 4th Saturdays off. To be considered for this position, you should have a qualification of M.Pharm/B.Pharm along with 5-15 years of relevant work experience in Regulatory Affairs-Clinical Trials for the EU and US markets. As part of your responsibilities, you will be involved in developing the Biosimilar Clinical Development Strategy, overseeing clinical trials and injectables for the EU and US markets. You will also be responsible for designing and finalizing clinical protocols, as well as managing Clinical Trial Applications and reviewing Clinical Study reports. Additionally, your role will include authoring and reviewing Biologics/Biosimilar Dossiers, with hands-on experience in eCTD submissions for the EU and US markets. You will handle Ministry of Health (MOH) queries, contribute to Product Life Cycle Management, and provide Regulatory Affairs support for plant-related Quality Management System (QMS) activities.,

Posted 1 week ago

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