Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation
Bachelor or Master degree in Pharmacy with a specialization in Pharmaceutics or Pharmaceutical Technology. Responsible to Organize and Co-ordinate Training Activities, Preparation of documents and Maintenance of training records. Responsible for material code initiation.
B.Pharm or M.Pharm qualification with atleast 20 years of experience and most recently have 3 years of experience in a multiline commercial manufacturing facility.
This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for New Drug Applications across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.
B.SC., M.Sc., B.Pharm, M.Pharm, B.Tech, M.Tech any Science; Responsible for check that Pharmaceutical products & Perform the analysis as per requirement of test request for R&D department.
Research new opportunities and manage company's entry and development strategy. To provide a weekly schedule of planned activities. Building business contact data from existing and new sources.