Regulatory Affairs Executive

Job Responsibility :

• Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA / NDA / MAA / ANDS).
• Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.
• Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements.
• Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.
• Ensure completeness and technical accuracy of eCTD sequences.
• Troubleshoot validation issues before final submission.
• Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes).
• Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA / IB / II).
• Collaborate with internal departments to gather data and draft scientifically sound responses.
• Stay updated with changes in FDA, EMA, and ICH guidelines.
• Maintain regulatory databases, submission trackers, and approval records.
• Participate in audits and support regulatory inspections.

Required Qualification & Skills :