Clinical Regulatory Executive post vacant @ Dr.Reddy’s Lab

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Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations

Position : Clinical Regulatory Executive

No of Post : 1

Duration : 1 – 3 years

Location : Hyderabad

Desired Profile : B.Sc Biotech/Pharma

Roles & Responsibilities :

  • Team member for Compilation of dossiers, preparation of Regulatory applications for Clinical Development of Biosimilars
  • Preparation of SAE packages for reporting to Regulatory Authority in India
  • Regulatory review of relevant documents pertinent to GCP, GVP and GCLP
  • Team member for Maintenance of commitment and compliance system for Clinical Development
  • Team member in establishment of Regulatory Management System (RMS) and maintain RMS for Clinical Development (SOPs, Work flows, Trackers, etc.)
  • Contribute in Regulatory assessment and Regulatory intelligence for Clinical Development
  • Any other work related to Regulatory Affairs for Clinical Development

Desirable expertise is as below :

  • 1-4 years of Regulatory prior work experience in Biotech/Pharma industry
  • Technical as well as good reasoning skills
  • Good interpersonal, behavioral, and learning attributes

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