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Job Description: Candidate with Master degree in Life Sciences/ Pharmaceutical Sciences having 4-8 years’ consistent experience in the vaccine/ biopharmaceutical industry, specifically in the recombinant products domain. He /She will be responsible for overseeing product registration, CMC, R&D projects, and WHO Prequalification (PQ) processes. This role requires an understanding of regulatory guidelines such as ICH, FDA, and EMA and country specific guidelines for ROW market particularly related to Vaccine, biologics and recombinant products. Capable of navigating the regulatory landscape with a proactive approach to problem-solving and a commitment to excellence in regulatory practices. Key Responsibilities: Lead the compilation of data for new R&D projects, focusing on the recombinant products domain, and manage multiple applications for import, research, and transfer activities. Collaborate with cross-functional teams to ensure the accurate and timely submission of product dossiers to the Drug regulatory authorities and RCGM. Regularly review and update the CMC sections of regulatory submissions to meet evolving regulatory requirements. Prepare and maintain CTD Master Documents for various vaccines, ensuring compliance with CTD, ACTD, and country-specific guidelines. Coordinate with manufacturing sites to facilitate all activities related to the WHO PQ process, including document compilation. Develop briefing documents, meeting requests, and responses to queries from regulatory agencies. Participate in pre-submission meetings and regulatory inspections, maintaining compliance with GCP, GDP, GMP, and other relevant standards. Support internal audits and inspections to ensure regulatory compliance across all functions. Manage the preparation of documents for product approvals, variations, and post-approval changes. Oversee the creation of Pre-Clinical Master documents for various vaccines, aligning with CTD, ACTD, and country-specific dossier requirements. Compile and review clinical trial protocols, investigator brochures, and study reports, providing a regulatory perspective on recombinant products. Handle post-approval regulatory activities, including CMC changes, labelling updates, safety reporting, and the preparation of annual reports. Show more Show less
