We are seeking a motivated and detail-oriented Regulatory Affairs qualified with 25 years of experience in ROW and EU markets. The candidate should have hands-on experience in dossier preparation, eCTD submissions lifecycle management activities, and coordination with cross-functional teams for regulatory submissions and compliance activities.

Key Responsibilities
Preparation, compilation, review, and submission of regulatory dossiers for ROW and EU markets in CTD/eCTD formats.
Handling new registrations, renewals, variations, responses to deficiency queries, and other post-approval submissions.
Expertise in eCTD software/tools and electronic submission management.
Preparation and review of Module 1 to Module 5 documents as per country-specific guidelines.
Lifecycle management activities including variations, renewals, notifications, amendments, artwork updates, and product name changes.
Coordination with internal departments such as QA, QC, Production, Packaging Development, and R&D; for regulatory documentation.




Tracking submission timelines and maintaining regulatory databases/document trackers.
Reviewing and ensuring compliance of labeling materials, SmPC, PIL, and artwork as per regulatory requirements.
Coordination with agents/distributors and regulatory authorities for submission-related activities and query responses.
Keeping updated with changing regulatory guidelines and market requirements for EU and ROW countries.
Support in dossier gap analysis and document deficiency management.

Required Skills & Competencies
Valuable knowledge of EU and ROW regulatory requirements.
Hands-on experience in eCTD submissions and publishing tools.
Robust understanding of lifecycle management activities.
Knowledge of CTD/eCTD structure and submission processes.
Experience in handling regulatory queries and deficiency responses.
Good communication, coordination, and documentation skills.
Ability to manage multiple projects within timelines

📌 Regulatory Affairs Executive Saki Naka (India)
🏢 Zenzi Pharmaceutical Industries
📍 India