Global Regulatory Submission Specialist

2 weeks ago


palakkad, India beBeeExpertise Full time

Regulatory Affairs ExpertAbout the Role:We are seeking an accomplished Regulatory Affairs Specialist to lead our global submissions.Author, compile, and submit regulatory dossiers to health authorities worldwide.Conduct thorough dossier gap analysis to identify document and data gaps across all CTD modules.Prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Manage end-to-end preparation and submission of lifecycle documents.Coordinate responses to health authority queries through cross-functional collaboration and data collation.Key Responsibilities:Lead regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between regulatory teams and stakeholders.Requirements:8–10 years of core experience in Regulatory Affairs, handling submissions globally.Strong understanding of global dossier formats and submission pathways.Excellent cross-functional communication and coordination skills.Proven ability to manage complex regulatory portfolios.



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