Senior Regulatory CMC Consultant

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.

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Habilidades

and recognizes your value.The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readinessMissions Lead the global Regulatory CMC strategy and support Marketing Authorization ApplicationsLead/review Module 3 preparation and submission activitiesSupport interactions with FDA, EMA and other Health Authorities, including responses to questions Identify regulatory risks and define appropriate mitigation strategiesOperate effectively within a global and cross-functional matrix environmentEnsure alignment of CMC regulatory strategies with overall development and commercialization objectivesCoordinate with cross-functional teams including CMC, Quality, Manufacturing, Regulatory and Technical teamsEnsure consistency, scientific robustness, and regulatory compliance of submission contentProvide strategic input regarding regulatory positioning and negotiation approachesEnsure compliance with applicable ICH and global regulatory requirementsRequirementsEducation : Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline.Experience : Solid experience in Regulatory CMC within the pharmaceutical industry, strong expertise in small molecules, proven experience with Module 3 and global Marketing Authorization Applications / NDA submissions

Skills : Strong knowledge of FDA, EMA and ICH.

Requisitos

Experience with international markets such as China, Japan, Brazil and.