Relevant several years of experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, health authority, or related environment * Experience supporting clinical development, marketing authorisation applications, lifecycle management, and post-authorisation regulatory activities * Experience preparing, reviewing, or contributing to regulatory submissions such as CTA, IND, NDA, BLA, MAA, variations, supplements, amendments, and responses to health authority questions * Experience supporting health authority interactions, submission planning, regulatory issue resolution, and lifecycle planning * Experience working effectively with cross-functional teams and external partners in a matrix environment
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