Full Time
Gurgaon
Posted 1 year ago

Job Description:

Summary

In this role, the candidate shall be responsible for researching, analysing, and summarizing complex regulatory information and translating it into insightful and compliant reports.

Responsibilities

  • Research and monitor regulatory requirements, guidelines, and industry trends from agency websites
  • Analize and interpret regulatory information in context and provide concise & accurate summary
  • Prepare high-quality, accurate, and compliant regulatory intelligence
  • Maintain up-to-date knowledge of global regulations & standards, and their implications
  • Assist in the development of regulatory strategies.
  • Ensure reports are delivered on time, meeting deadlines, and expectations
  • Support regulation submissions as needed

Qualifications

  • BSc/B. Pharm in related field (Life Sciences, Pharmacy, Regulatory Affairs, or similar discipline)
  • 2+ years of experience in scientific report writing
  • Robust research and analytical skills with the ability to process and communicate complex/technical information
  • Exceptional English written and verbal communication skills
  • Attention to detail and ability to work with highly technical and scientific content
  • Time management and organizational skills, with the ability to prioritize tasks effectively
  • Familiar with regulations and guidelines (i.e., US FDA, EMA, UK MHRA, ICH)
  • Familiar with navigating through regulatory agency websites to search for relevant/applicable guidelines
  • A certification in regulatory affairs is a plus

Location

Gurgaon

 

 

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