Regulatory Affairs Executive

Regulatory Affairs Executive :

(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 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.