Intas Pharmaceuticals | Manager/Sr. Manager

1 month ago


india Intas Pharmaceuticals Full time

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.



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