API Regulatory Compliance Specialist
I
Intas Pharmaceuticals
📍 Ahmedabad, Gujarat, India
Job Description
We’re hiring
API - Regulatory Affairs professionals
!
Join us to drive global DMF submissions, regulatory compliance, and strategic market access.
Apply now and grow with a high-impact team. We are seeking a dynamic and detail-oriented professional to manage end-to-end regulatory submissions and lifecycle activities for API dossiers across global markets. The role plays a critical part in ensuring timely approvals, regulatory compliance, and seamless coordination across functions.
Regulatory Submissions & DMF Management :
Prepare, review, and submit
Drug Master Files (DMFs)
in compliance with global regulatory requirements and Manage full
DMF lifecycle
including amendments, annual updates, and variations
Ensure timely submission of regulatory dossiers and responses to health authorities
Maintain accurate tracking and documentation of DMFs, LOAs, and deficiency responses
Technical Evaluation & D...
API - Regulatory Affairs professionals
!
Join us to drive global DMF submissions, regulatory compliance, and strategic market access.
Apply now and grow with a high-impact team. We are seeking a dynamic and detail-oriented professional to manage end-to-end regulatory submissions and lifecycle activities for API dossiers across global markets. The role plays a critical part in ensuring timely approvals, regulatory compliance, and seamless coordination across functions.
Regulatory Submissions & DMF Management :
Prepare, review, and submit
Drug Master Files (DMFs)
in compliance with global regulatory requirements and Manage full
DMF lifecycle
including amendments, annual updates, and variations
Ensure timely submission of regulatory dossiers and responses to health authorities
Maintain accurate tracking and documentation of DMFs, LOAs, and deficiency responses
Technical Evaluation & D...