Regulatory Affairs Specialist

3 days ago

tumakuru, India beBeeRegulatoryAffairs Full time

Position OverviewWe are seeking an accomplished Regulatory Affairs Professional to manage regulatory submissions for multiple products across various countries.This role involves ensuring compliance with global health authority regulations and guidelines. The ideal candidate will possess strong knowledge of dossier formats, submission pathways, and lifecycle management.Strong understanding of global regulatory requirements and guidelines.Experience in managing complex multi-country regulatory portfolios.Excellent cross-functional communication and coordination skills.DescriptionIn this critical role, you will be responsible for coordinating responses to health authority queries through cross-functional collaboration and data collation. You will also maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.You will utilize project management tools to track project milestones, timelines, and deliverables. Furthermore, you will foster seamless communication between central regulatory, regional teams, and client stakeholders to ensure efficient time and resource allocation.Key Responsibilities:Regulatory Submissions & Compliance:Author, compile, and submit regulatory dossiers to global health authorities.Conduct dossier gap analysis to identify document and data gaps.Convert and prepare dossiers in multiple formats.Project Planning & Management:Manage regulatory submissions for multiple products across multiple countries.Ensure efficient time and resource allocation to meet submission deadlines.Requirements:To succeed in this role, the ideal candidate should possess 8-10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.BenefitsThe successful candidate will have the opportunity to work in a dynamic environment with a talented team of professionals. They will also receive comprehensive training and development opportunities to enhance their skills and expertise.About UsWe are a leading organization dedicated to providing innovative solutions in the field of healthcare. We strive to make a positive impact on society by delivering high-quality products and services that improve people's lives.

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