Regulatory Affairs Expert

2 weeks ago

nashik, India beBeeProfessional Full time

Regulatory Affairs ProfessionalJob OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for managing and coordinating the preparation and submission of regulatory documents for various products.Manage end-to-end preparation and submission of regulatory dossiers to global health authorities.Conduct dossier gap analysis to identify document and data gaps.Prepare and submit regulatory documents in multiple formats.Coordinate responses to health authority queries through cross-functional collaboration.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation.Key ResponsibilitiesDevelop and implement regulatory strategies for new product launches.Manage regulatory submissions for multiple products across multiple countries simultaneously.Ensure compliance with regulatory requirements and guidelines.Collaborate with cross-functional teams to ensure seamless communication.Requirements8–10 years of experience in Regulatory Affairs.Strong understanding of global dossier formats and submission pathways.Excellent cross-functional communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.If you have the necessary qualifications and experience, please apply for this exciting opportunity to grow your career as a Regulatory Affairs Professional.

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