Global Regulatory Compliance Professional

3 days ago

Gandhinagar, India beBeeRegulation Full time

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for managing regulatory submissions for multiple products across multiple countries, ensuring efficient time and resource allocation to meet submission deadlines.The ideal candidate will have 8-10 years of core experience in Regulatory Affairs, a strong understanding of global dossier formats, submission pathways, and lifecycle management.Key Responsibilities:Authoring, compiling, and submitting regulatory dossiers to global health authorities.Conducting dossier gap analysis to identify document and data gaps.Converting and preparing dossiers in multiple formats.Managing end-to-end preparation and submission of lifecycle submissions.Coordinating responses to health authority queries through cross-functional collaboration and data collation.Project Planning & Management:Managing regulatory submissions for multiple products across multiple countries simultaneously.Utilizing project management tools to track project milestones, timelines, and deliverables.Ensuring efficient time and resource allocation to meet submission deadlines.Fostering seamless communication between central regulatory, regional teams, and client stakeholders.RequirementsA bachelor's degree in life sciences or a related field.8-10 years of core experience in Regulatory Affairs.A strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.A proven ability to manage complex multi-country regulatory portfolios.Why This Role?This is an exciting opportunity for a motivated and experienced Regulatory Affairs Specialist to take on a challenging role and make a meaningful contribution to our organization.Our company is committed to providing a supportive and collaborative work environment that allows our employees to grow and develop their careers.

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