Biologics, Regulatory Affairs- CMC

About the Company USV , a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India. We specialise in niche product areas across international markets, including Oral Solid Dosages (OSD), sterile products, peptides, biologics, and...

We are seeking an experiencedRegulatory Affairs professionalto lead and executeglobal regulatory strategiesfor biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals acrossUS, EU,...

Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...

The Formulation Lead for Biologics formulation will be responsible for leading the developmentand optimization of formulations for a range of Biologics drug products like mAbs, Bispecifics, ADCs, Fusion MAbs etc. The successful candidate will advise and consult the formulation development teams on designing and developing robust and scalable formulations.Key...

The Formulation Lead for Biologics formulation will be responsible for leading the developmentand optimization of formulations for a range of Biologics drug products like mAbs, Bispecifics, ADCs, Fusion MAbs etc. The successful candidate will advise and consult the formulation development teams on designing and developing robust and scalable formulations.Key...

The Formulation Lead for Biologics formulation will be responsible for leading the development and optimization of formulations for a range of Biologics drug products like mAbs, Bispecifics, ADCs, Fusion MAbs etc. The successful candidate will advise and consult the formulation development teams on designing and developing robust and scalable...

About UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing indata engineering, cloud transformations, and AI-powered analyticsfor Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview: We are seeking aRegulatory Affairs Subject Matter Expert...

About UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing indata engineering, cloud transformations, and AI-powered analyticsfor Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview: We are seeking aRegulatory Affairs Subject Matter Expert...