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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