Qualifications: Science Graduate/Postgraduate (Pharmaceutical/Biotechnology Domain) Experience: > 10 years of experience including team handling experience in similar domain Job Responsibility: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: - A. Keep up to date with the current regulatory guidelines and regulatory approval system B. Maintaining/approving of Regulatory & QA documentation C. Any other responsibility assigned by the management.
Job Title
Intas Pharmaceuticals | Manager/Sr. Manager - Regulatory Affairs (Biologics)