Executive Regulatory Affairs

Isshaan Healthcare; Dadri; Sur place; INR 700 000 - 1 100 000; Plein temps

Résumé du poste

Isshaan Healthcare in India is seeking a Regulatory Affairs Executive to lead regulatory compilations and submissions for international markets. The role involves coordinating across R&D, QA, QC, production and logistics to secure approvals and manage lifecycle activities.

The ideal candidate will have 2–5 years of regulatory experience handling submissions for ROW, CIS, Africa, SEA and Asian markets, ensuring compliance with country-specific guidelines.

Qualifications

• Experience compiling and submitting regulatory dossiers for international markets (ROW, CIS, Africa, SEA, Asia).
• Proven ability to manage lifecycle activities including post-approval changes and renewals.
• Strong coordination with R&D, QA, QC, Production and Logistics to gather required documents.

Responsabilités

• Prepare, review, and compile regulatory dossiers in CTD/ACTD formats for multiple regions.
• Address MOH/FDA technical queries to secure timely product approvals.
• Track changes in regulatory guidelines and ensure ongoing compliance for registrations.

Connaissances

Regulatory submissions

Documentation

Cross-functional coordination

Attention to detail

Description du poste

Role & responsibilities

• Dossier Compilation & Submission: Prepare, review, and compile regulatory dossiers in CTD, ACTD, and country-specific formats for ROW, CIS, Africa, SEA, and Asian regions.
• Query Management: Promptly address and resolve technical queries raised by Ministry of Health (MOH) / FDA authorities of respective countries to ensure timely product approvals.
• Lifecycle Management: Manage post-approval changes, variations, and timely renewal of product registrations and manufacturing licenses.
• Artwork & Labeling Review: Review and approve product packaging artwork, labels, and Patient Information Leaflets (PIL) as per the specific countrys regulatory guidelines.
• Cross-Functional Coordination: Collaborate with R&D, Quality Control (QC), Quality Assurance (QA), Production, and Export/Logistics teams to gather required technical documents and data.
• Regulatory Intelligence: Track and update internal teams on changing regulatory guidelines and import/export compliance rules in the assigned regions.

Preferred candidate profile

We are looking for a dynamic and result-oriented Regulatory Affairs Executive with 2 to 5 years of experience in handling regulatory compilations and submissions for international markets. The ideal candidate will be responsible for managing product registrations and life‑cycle management across ROW, CIS, Africa, SEA, and Asian markets.