Senior Regulatory Compliance Professional

2 weeks ago

kannur, India beBeeRegulatory Full time

Regulatory Affairs SpecialistWe are seeking a skilled 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 and submission pathways.Job ResponsibilitiesRegulatory Submissions: Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Dossier Gap Analysis: Conduct analysis to identify document and data gaps across all CTD modules (1–5).Document Preparation: Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Lifecycle Management: Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Query Response: Coordinate responses to health authority queries through cross-functional collaboration and data collation.Project Planning & ManagementMulti-Country Management: Manage regulatory submissions for multiple products across multiple countries simultaneously.Project Tools: Utilize project management tools to track project milestones, timelines, and deliverables.Time and Resource Allocation: Ensure efficient time and resource allocation to meet submission deadlines.Cross-Functional Communication: Foster seamless communication between central regulatory, regional teams, and client stakeholders.RequirementsExperience: 8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Global Understanding: Strong understanding of global dossier formats, submission pathways, and lifecycle management.Communication Skills: Excellent cross-functional communication and coordination skills.Portfolio Management: Proven ability to manage complex multi-country regulatory portfolios.

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