Regulatory Affairs Executive / Sr. Executive

We are seeking a motivated and detail-oriented Regulatory Affairs professional 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

• Good knowledge of EU and ROW regulatory requirements.
• Hands-on experience in eCTD submissions and publishing tools.
• Strong 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.

Proficiency in Microsoft Office applications