Senior Regulatory Affairs Executive

2 weeks ago


kakinada, India beBeeRegulatory Full time

Regulatory Affairs ProfessionalAbout the Role:Regulatory Submissions & ComplianceWe are seeking a highly skilled Regulatory Affairs Specialist to author, compile, and submit regulatory dossiers to global health authorities.The successful candidate will conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Responsibilities include converting and preparing dossiers in multiple formats including eCTD, ACTD, and CTD.This role also involves managing end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Candidates must be able to coordinate responses to health authority queries through cross-functional collaboration and data collation.A strong command over CMC, clinical, non-clinical, and administrative documentation is essential to ensure successful global submissions.Project Planning & ManagementManage regulatory submissions for multiple products across multiple countries simultaneously.This includes utilizing project management tools to track project milestones, timelines, and deliverables.The ideal candidate will ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:A minimum of 8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.A strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.



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