Regulatory Affairs Professional

3 days ago


Delhi, Delhi, India Immuneel Therapeutics Pvt. Ltd. Full time

We're passionate about developing innovative solutions that drive patient outcomes and improve lives.

Our goal is to create a world where patients have access to life-changing treatments, and we're seeking a talented professional to join our team as a Regulatory Affairs Specialist.

In this role, you will be responsible for managing and supporting regulatory submissions, ensuring compliance with global regulatory requirements, and maintaining the highest standards of operational efficiency in regulatory processes.

You will work closely with our site Regulatory Affairs and Quality teams to ensure regulatory submissions and audit compliance.

Competencies Required:
  • Deep understanding of the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars issued by the CDSCO
  • Familiarity with clinical trial regulations, including Good Clinical Practices (GCP) and the New Drugs and Clinical Trials Rules, 2019
  • Excellent writing skills to prepare clear, concise, and accurate regulatory documents


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