BKM is seeking a Regulatory Affairs Executive to join our team In this role you will be responsible for getting new products approval from the regulated market In depth knowledge of US FDA EMA and ICH regulatory frameworks eCTD ACTD dossier preparation compilation and submission Familiar with regulatory tools like Extedo Lorenz Veeva Vault RIM Job Responsibility Prepare compile and review CTD eCTD dossiers for submissions e g ANDA NDA MAA Coordinate with cross functional teams QA QC R D Manufacturing Packaging for accurate documentation Submit applications to US FDA 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 app roval 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 sc ientifically 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 3 10 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 Experience 5 to 10 years Location Ahmedabad Gujarat On site Job Types Full-time Permanent Pay 50 000 00 - 80 000 00 per month Advantages Paid sick time Paid time off Schedule Day shift Fixed shift Application Question s How many years of Health Canada experience do you have Are you comfortable with onsite working Location Gota Ahmedabad Gujarat Required Work Location In person

📌 Regulatory Affairs Executive (Gujarat)
🏢 BKM Health
📍 Gujarat