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.
