Jabeen Unissa

Junior Regulatory Associate @Navitas Life Sciences

Chennai, IN

Preparing Regulatory Submission documents, particularly in the context of eCTD, CTD, and paper submissions.• My responsibilities included managing global publishing requirements based on SOPs for various submissions, including EU CMC, US FDA, and Health Canada, ensuring compliance with the specific requirements of each regulatory authority.• EU Dossier Manager of MAA National category including EU CMC, Labelling Type IA and IB variation covering all regions of EU Market performing end-to-end submission and dispatching to EMA agency via CESP Portal.• Additionally, I have worked on special projects, such as Safety Submission and Clinical Study Report (CSR), where I ensured that all documentation was accurate and submitted in a timely manner. • My experience also includes conducting thorough reviews of documents to ensure they meet the necessary standards and guidelines.• I utilized tools like Veeva Vault, Adobe Acrobat and Lorenz e-Validator to streamline the document preparation and submission process, which has been vital in my current role.• Overall, my hands-on experience with regulatory submissions has equipped me with the skills needed to assist with the preparation of INDs, NDAs, and other regulatory documents effectively.

BSA Crescent Institute of Science and Technology

Bachelor of Pharmacy - BPharm, Pharmacy