Manager-Biologics Regulatory Affairs

7 hours ago

Mumbai, Maharashtra, India USV PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 18,00,000 per year

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables for EU and US markets. - Designing and developing clinical protocols for Biosimilar Clinical trials, ensuring review and finalization for EU and US markets. - Handling Biosimilar Clinical Trial Applications, providing an overview of clinical study conduct, reviewing Clinical Study reports, and finalizing them for EU and US markets. - Authoring and reviewing Biologics/Biosimilar Dossiers, with hands-on experience in eCTD submissions for the EU and US markets. - Managing Ministry of Health (MOH) queries and responses effectively. - Contributing to Product Life Cycle Management activities. - Providing Regulatory Affairs support for plant-related Quality Management System (QMS) activities. The desired qualification for this position is M.Pharm/B.Pharm, and the ideal candidate should have 5-15 years of work experience in Regulatory Affairs specifically focusing on Clinical Trials for the EU and US markets. USV Private Limited is a top-15 pharmaceutical company in India, excelling in the diabetes and cardio sectors with a global presence in over 65 countries. The company values innovation, quality, and a commitment to improving healthcare outcomes for patients worldwide.,

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