Sr. Manager/AGM Regulatory Affairs

Job Description:

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• 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.

• 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.
   

• Keep up to date with the current regulatory guidelines and regulatory approval system  
• Maintaining/approving of Regulatory & QA documentation 
• Any other responsibility assigned by the management.