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 new 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
🏢 Search Advisers Services ( GUJ
📍 Ankleshwar