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Hiring Assistance Manager_ Regulatory Affair for Delhi Location Excel Life Sciences Pvt Ltd

  • Experience: 2 - 4 years
  • Location: Delhi
  • Role: Drug Regulatory Director
  • Category: Management Jobs
  • Posted: Mon, Feb 20, 2017
Skills: Export, Hiring, Regulatory, Affairs, Clinical Trials, Medical Devices

Job Description

Preparing dossiers for registration of clinical trials (devices and drugs etc.)
Filing the submissions for devices, clinical trials, drug-approvals, NOCs
Getting approvals, Import/Export licenses of medical devices, drugs and clinical trials
To address queries in support of queries for applications and responses
CTRI registration and follow up for queries
Preparation of protocol with support from operations (if required)
Tracking the submission of SAEs, SUSARs and CIOMS
Having interpersonal communication and network with regulatory
Training on regulatory topics
Updating regulatory SOPs in conjunction with Compliance department

 

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