Global Regulatory Expert

3 days ago

amravati, India beBeeRegulatory Full time

Regulatory Affairs SpecialistAs a Regulatory Affairs Specialist, you will be responsible for managing the regulatory lifecycle of products across multiple countries.Ensure compliance with global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier 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 end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Collaborate with cross-functional teams to respond to health authority queries.Project Planning & ManagementCoordinate regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Efficiently allocate resources to meet submission deadlines.Foster effective communication between central regulatory, regional teams, and client stakeholders.Requirements8-10 years of experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent collaboration and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.The ideal candidate will have:A deep understanding of global regulatory environments.Exceptional organizational and time management skills.The ability to work effectively in a fast-paced environment.A strong attention to detail and ability to prioritize tasks.We offer:A dynamic and supportive work environment.Ongoing training and development opportunities.The chance to work on challenging and diverse projects.

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