Role & responsibilities

Role Overview

Responsible for preparation, review, and submission of regulatory dossiers for APIs (DMFs, ASMFs, CEPs) in compliance with global regulatory requirements. The role involves coordinating with cross-functional teams, handling authority queries, and ensuring timely submissions for recent registrations and lifecycle management.

Key Responsibilities
Prepare and review DMFs, ASMFs, CEPs, and other regulatory dossiers for APIs.
Ensure compliance with global guidelines (USFDA, EMA, EDQM, WHO, CDSCO, etc.).
Manage regulatory queries and coordinate with internal teams for data/information.
Support variations, renewals, and post-approval changes.
Maintain regulatory documentation, databases, and ensure audit readiness.
Stay updated with changing ICH and international regulatory guidelines.
Knowledge of CTD/eCTD formats, ICH guidelines, global filing requirements.
Valuable communication and coordination skills.

Preferred candidate profile

📌 Sr Exe To Asst Mgr Ra Api , Ankleshwar (India)
🏢 Search Advisers Services ( GUJ
📍 India