Senior Global Regulatory Specialist

5 days ago

erode, India beBeeRegulatory Full time

Global Regulatory SpecialistThis role involves managing regulatory submissions for multiple products across various countries.Author and compile regulatory dossiers, submit to global health authoritiesConduct dossier gap analysis, identify document and data gapsConvert and prepare dossiers in eCTD, ACTD, CTD formatsManage end-to-end preparation and submission of ANDA, NDA, BLA, MAACoordinate responses to health authority queries through collaborationMaintain strong command over CMC, clinical, non-clinical documentationProject Planning & ManagementManage regulatory submissions for multiple products across countriesUtilize project management tools to track milestones, timelinesEarn efficient time and resource allocation to meet submission deadlinesFoster seamless communication between teams and client stakeholdersRequirements8-10 years experience in Regulatory Affairs, handling submissions across regulated marketsStrong understanding of global dossier formats, submission pathwaysExcellent cross-functional communication and coordination skillsProven ability to manage complex multi-country portfoliosOur ExpectationsWe are looking for a skilled professional who can effectively coordinate and manage the process of submitting regulatory documents on behalf of our clients. This role requires a high level of expertise in regulatory affairs, including knowledge of global dossier formats and submission pathways.The ideal candidate will have excellent cross-functional communication and coordination skills, with the ability to work seamlessly with internal teams and external partners.Key aspects of this role include:Developing and implementing effective regulatory strategies to meet client needsManaging and coordinating the preparation and submission of regulatory documentsBuilding and maintaining relationships with key stakeholders, including clients, regulatory authorities, and industry partners

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