Senior Regulatory Compliance Specialist

5 days ago

india beBeeExpertise Full time

Regulatory Affairs ExpertThe Regulatory Affairs Specialist will be responsible for overseeing regulatory submissions, ensuring compliance with global health authorities, and coordinating responses to queries.Main Responsibilities:Author, compile, and submit regulatory dossiers to global health authorities.Conduct dossier gap analysis and convert dossiers in multiple formats.Manage end-to-end preparation and submission of lifecycle submissions.Coordinate responses to health authority queries through cross-functional collaboration.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation.Project Planning & Management:Oversee regulatory submissions for multiple products across multiple countries.Utilize project management tools to track project milestones and timelines.Ensure efficient time and resource allocation to meet submission deadlines.Requirements:8–10 years of core experience in Regulatory Affairs.Strong understanding of global dossier formats and submission pathways.Excellent communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.This role requires exceptional organizational skills and the ability to prioritize tasks effectively. The successful candidate will have a proven track record of meeting deadlines and delivering high-quality results under pressure.The ideal candidate will have excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. They will also have a strong understanding of global regulations and guidelines, as well as experience working with regulatory agencies.

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