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:

- Bachelor's / Master’s degree in Pharmacy or related field. - 1.5 – 2 years of relevant experience in Regulatory Affairs for regulated markets (Health Canada/US/EU) - In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks. - Strong understanding of dossier structure, eCTD publishing, and submission timelines.