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Regulatory Compliance Specialist

1 month ago


Mumbai, Maharashtra, India Indian Institute of Technology Bombay Development and Relations Foundation (IITB DRF) Full time

Job Summary

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at the Indian Institute of Technology Bombay Development and Relations Foundation (IITB DRF) in Mumbai. As a key member of our quality assurance team, you will play a critical role in ensuring compliance with Good Manufacturing Practice (GMP) regulations and standards.

About Us

The Indian Institute of Technology Bombay Development and Relations Foundation (IITB DRF) is a premier educational institute in India dedicated to supporting innovations in novel drug and device development. Our 10X GMP facility is designed to manufacture early-stage clinical supplies of drugs and devices, catering to a diverse range of product types.

Your Role

As a Regulatory Compliance Specialist, you will be responsible for executing quality and compliance aspects of the 10X GMP facility, ensuring timely execution of all quality reviews, batch releases, CAPAs, change controls, and regulatory submissions. You will work closely with the Head in Charge and QA Lead to develop and implement quality programs, maintain records, and support documentation development.

You will also develop and execute training programs for project scientists on quality systems, policies, and regulatory requirements. Your primary responsibilities will include: