Global Regulatory Submission Expert

2 weeks ago

aligarh, India beBeeRegulatory Full time

Global Regulatory Submission ExpertThis role requires a strong understanding of global dossier formats, submission pathways, and lifecycle management.The ideal candidate will have 8-10 years of core experience in Regulatory Affairs, handling submissions across regulated markets.The key responsibilities include:Author, compile, and submit regulatory dossiers to global health authorities.Conduct dossier gap analysis to identify document gaps.Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions.Coordinate responses to health authority queries through cross-functional collaboration.Maintain a strong command over CMC, clinical, non-clinical documentation.The project planning and management skills required include:Managing regulatory submissions for multiple products across 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 regulatory teams and stakeholders.Vision and ObjectivesWe are looking for an expert in global regulatory submissions who can take on the responsibility of preparing and submitting high-quality documents to health authorities.The right person will be able to lead the team in managing the lifecycle of various submissions, from initial application to final approval.We aim to build a collaborative work environment where our Regulatory Affairs Specialist can excel and contribute to the success of the company.What We OfferWe offer a competitive compensation package, opportunities for career growth and professional development, and a dynamic work environment that values innovation and teamwork.Our team is passionate about delivering high-quality results and making a positive impact in the industry.If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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