- 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).
- Strong 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.
- Strong communication skills for effective coordination with internal teams and external stakeholders.
📌 Executive - RA - HO - 6946 (Ahmedabad)
🏢 Troikaa Group
📍 Ahmedabad
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