Strategic Regulatory Compliance Manager

2 weeks ago


kochi, India beBeeRegulatoryAffairs Full time

Regulatory Affairs Specialist Role OverviewAs a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with global regulatory standards. The position involves authoring, compiling, and submitting regulatory dossiers to health authorities.Authoring and compiling regulatory dossiers for submission to health authoritiesConducting dossier gap analysis and preparing documents for submissionsManaging end-to-end preparation and submission of lifecycle submissionsThe successful candidate will have experience in Regulatory Affairs with submissions across regulated and RoW markets, as well as strong communication and coordination skills.Key responsibilities include:Managing regulatory submissions for multiple products across countriesUtilizing project management tools to track milestones, timelines, and deliverablesFostering seamless communication between teams and stakeholdersThis is a complex role requiring a strong command over CMC, clinical, non-clinical, and administrative documentation, as well as the ability to manage complex multi-country regulatory portfolios.Required Skills and QualificationsExperience in Regulatory Affairs with submissions across regulated and RoW marketsStrong understanding of global dossier formats, submission pathways, and lifecycle managementExcellent communication and coordination skillsBenefitsOpportunity to work on complex regulatory projectsCollaborative team environmentProfessional growth and development opportunities



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