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