Naprod Life Sciences Pvt Ltd
NMM GROUP have openings with RA department
Title of vacancy – Executive / Assistant Manager – RA
Content (JD) –
Plan and schedule dossier as per BDM requirement and priority for SRA countries. On reciept of DRF, pDRF, procurement of documents and other requirements from various departments to initiate on timely manner.
Ensuring the documentations related to regulatory submissions necessary to support clinical trials/BE studies, DCGI & product registration and life cycle management (Renewal, variations and Queries) are catered within the specific internal or external (MOH) deadline.
Planning and Execution the stratergy with the team to accomplish the task within the stipulated timelines.
Prepare an implementation plan of 3 to 6 months based on the strategy plan.
” Planning and Execution of the RA plan for Dossier quality, timely transfers, Variations, Renewals and Queries in timely manner. Analyse the trend of RA on quarterly basis and present it to HOD on any changes to be made.”
Timely input about the necessary information on RA Budget where cost is incurred.
“Analyze the BDM requirement and plan and schedule dossier priorities on quarterly and monthly basis Align the documentations on reciept as per the required protocol and internal approval of DRF. Align the necessary actions required for the project DRF on regular basis to make timely submissions as agreed with the BDM. Analyse and review the monthly status on Registration, submission and transfer and communicate the same to HOD in case of any discrpency.”
“1. Review the Master document for data initegrity . 2. Review of document for under compilation dossier to meet the country’s specific requirement for new products. 3. Create RA Knowledge bank with details about all the norms, legislations and guidelines in various countries to which RA needs to abide.”
“Update the ready recknor for new Country , update all status for tracking the related activity. Archival of Comunication, additional document ,query response, updated document and submitted dossier. Ensure that the RA tracker is always updated for regulatory activities like dossier submissions, Renewals, Variations, Queries along with Marketing status of all products . Ensure all RA related documents are archived and saved in respective folders with appropriate nomenclature.”
Analyze the performance matrix and provide the inputs for taking appropriate decision related to increments, development plan, replacement, promotion etc.
Qualification – B. Sc, M. Sc, B Pharm, M Pharm
Experience 5 – 8 yrs of RA department working with ROW market
Location of working – Palghar Boisar
Contact – Share profiles on [email protected]