What You'll Do
Prepare, compile, and review regulatory dossiers for new product registrations, renewals, variations, query responses, and tenders for ROW markets in line with country-specific guidelines.
Coordinate with cross-functional teams (R&D;, Quality Assurance, Manufacturing, and Marketing) to gather and verify technical and administrative documents.
Ensure dossiers are prepared in the required formats (CTD, ACTD, or country-specific) and meet submission timelines.
Track and manage dossier status, regulatory queries, and approvals using internal systems.
Liaise with regulatory agencies or local partners to clarify requirements and resolve submission-related issues.
Maintain up-to-date knowledge of regulatory guidelines, changes, and best practices for ROW markets.

What You'll Bring




Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
2–5 years of experience in dossier preparation for ROW markets (recent registrations, renewals, variations, and query handling).
Solid understanding of CTD/ACTD formats and country-specific regulatory requirements.
Excellent attention to detail, organizational skills, and ability to manage multiple projects simultaneously.
Proficiency in MS Office and document management systems.
Robust communication skills for effective coordination with internal teams and external stakeholders.

📌 Executive Ra Ho 6946 Ahmedabad
🏢 Troikaa Group
📍 Ahmedabad