Regulatory Affairs Specialist

1 week ago

Odhav, India BKM Health Pvt Ltd Full time

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.

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