Global Regulatory Compliance Specialist

13 hours ago


kottayam, India beBeeCompliance Full time

Regulatory Affairs Specialist RoleThis specialist plays a pivotal role in ensuring global regulatory compliance and submissions.The specialist must conduct thorough dossier gap analysis to identify document and data gaps across all CTD modules (1–5).This includes converting and preparing dossiers in multiple formats including eCTD, ACTD, and CTD.The specialist will manage the end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions, as well as coordinating responses to health authority queries through cross-functional collaboration.Responsibilities include handling submissions across regulated and RoW markets with strong understanding of global dossier formats, submission pathways, and lifecycle management.RequirementsThe ideal candidate should possess 8–10 years of core experience in Regulatory Affairs. This role requires strong knowledge of global regulatory environments, clinical trials, and quality assurance.Expertise in dossier formatting and submission processes is essential.Ability to analyze complex data and ensure compliance with regulatory requirements is critical.Strong communication and project management skills are necessary for effective collaboration and coordination.BenefitsThis role offers opportunities for professional growth and development in a dynamic and challenging environment.The ideal candidate will have a strong understanding of global regulatory landscapes, clinical trial operations, and quality systems.What We OfferWe offer a competitive salary and benefits package, as well as opportunities for professional development and advancement.The successful candidate will be able to work independently and collaboratively as part of a team, with excellent communication and project management skills.



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