Global Regulatory Affairs Expert

6 days ago

kakinada, India beBeeRegulatory Full time

Regulatory Affairs Professional OpportunityWe are seeking a seasoned Regulatory Affairs Specialist to join our team.The ideal candidate will have 8-10 years of experience in regulatory affairs, with a strong understanding of global dossier formats, submission pathways, and lifecycle management.This role involves managing simultaneous regulatory submissions for multiple products across various countries. The specialist will conduct dossier gap analysis, identify document and data gaps, and convert dossiers into multiple formats.Key responsibilities include:Authoring, compiling, and submitting dossiers to global health authoritiesConducting dossier gap analysis and identifying document and data gapsPreparing dossiers in multiple formats, including eCTD, ACTD, and CTDA successful candidate will have excellent project management skills, ensuring seamless communication between central regulatory, regional teams, and client stakeholders.Core Requirements:8-10 years of core experience in regulatory affairsHandling submissions across regulated and RoW marketsBenefits:Ongoing professional development opportunitiesCollaborative and dynamic work environment

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