Regulatory Affairs Professional

2 weeks ago

Tirupati, India beBeeRegulatory Full time

Regulatory Affairs Specialist – Key ResponsibilitiesWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for authoring, compiling, and submitting regulatory dossiers to global health authorities.Author and compile regulatory dossiers for submission to various health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct gap analysis to identify document and data gaps across all CTD modules (1–5).Prepare and submit dossiers in multiple formats, including eCTD, ACTD, and CTD.Manage the end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions.Coordinate responses to health authority queries through cross-functional collaboration and data collation.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.Project Planning & ManagementYou will also be responsible for managing 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 central regulatory, regional teams, and client stakeholders.RequirementsTo succeed in this role, you will need: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.A proven ability to manage complex multi-country regulatory portfolios.

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