Associate Regulatory Affairs

Dr. Reddy's Laboratories Ltd.

Princeton, NJ, United States
Base: determined on role, experience, skill set + ...
On-site
3 to 5 years regulatory affairs experience
Hands on cmc document review
Anda submission process knowledge
Dr. Reddy's Laboratories is seeking an Associate Regulatory Affairs professional to join their Princeton, NJ office. The role involves managing regulatory documentation, supporting the submission process for ANDAs, and facilitating communication with the FDA, while contributing to the company's mission of improving healthcare through innovation and affordability

Job Summary

  • The company is dedicated to making breakthroughs a reality by helping people lead longer and healthier lives through affordable medicines.
  • The incumbent will be responsible for maintaining regulatory documentation, reviewing CMC documents, and supporting post-approval changes for ANDAs.
  • Employees are eligible for a competitive total rewards package including base salary, discretionary bonus, and comprehensive health care coverage.

Matching Summary

Match Score: 85

Dr. Reddy's Laboratories is seeking an Associate Regulatory Affairs professional to join their Princeton, NJ office. The role involves managing regulatory documentation, supporting the submission process for ANDAs, and facilitating communication with the FDA, while contributing to the company's mission of improving healthcare through innovation and affordability.

Salary

Base: determined on role, experience, skill set and location; Bonus: annual discretionary bonus; Benefits: comprehensive health care, retirement savings plan, leave benefits

Skills & Requirements

Must-have

  • 3 to 5 years regulatory affairs experience
  • Hands on CMC document review
  • ANDA submission process knowledge
  • USFDA interaction capabilities
  • In-person work in Princeton NJ

Nice-to-have

  • Experience with analytical method validation
  • Diverse cultural group collaboration
  • Strong organizational time management skills
  • Ability to manage multiple projects simultaneously

Key Requirements

  • Degree in Pharma
  • 3 to 5 years experience in regulatory affairs
  • Must be US citizen or lawful permanent resident

Work Rights

Must have US citizenship or lawful permanent resident status

Tailored Resume

Cover Letter