Job Description

Experience: 10+ years of experience including team handling experience in similar domainLocation: Ahmedabad, GujaratSummary of Profile specifications:Incumbent should have sound knowledge of domestic regulatory functions with ref to DBT-RCGM, CDSCO and state FDA regulations.He/she should be a seasoned professional with leadership qualities, have knowledge about NDCT rules, Biosimilar guidelines, cGMP requirements and IBSC functioning. Team handling is an essential requirement for this role.Candidate should have sound knowledge of development documents of biologic product as per the requirements of approving authorities.Responsible for overall regulatory activities including reviewing, submissions and applications for product approvals and compliance for India Market with special focus on r-DNA products (with all relevant government agencies).Good knowledge about CGT (cell and gene therapy) products would be of added advantage.Key Responsibilities:Preparation and submission of applications and dossier for registration of recombinant products (innovative and biosimilars), CGT products in India (own manufacturing as well as import registration).Preparation and submission of dossier to RCGM for approval of PCT application (dept of Biotechnology).Responsible for IBSC (institutional biosafety committee) meeting conduction and related regulatory activities.Review and timebound submission of application for MAA, PAC, CT (Phase I, II and Phase III applications), Form 11, Form CT-10, Form CT-16, Dual Use NOC to obtain relevant DCGI approvals.Review and timebound submission of application for (GMP inclusion/ renewal of manufacturing license, COPP, FDCA application to obtain relevant FDCA approvals.Preparation of draft label for domestic market as per D&C Act.Updating, preparing and review of the dossier and documents as well as responses to the queries raised by regulatory agencies for India market.Imparting training for preparation of documents and guidance to subordinates.Co ordination with internal and external stakeholders for successful regulatory approval of the products.Additional Responsibilities:Keep up to date with the current regulatory guidelines and regulatory approval systemMaintaining/approving of Regulatory & QA documentationAny other responsibility assigned by the management.

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