Job Title: Global CMC Regulatory Affairs Associate Position Description This position will be directly responsible for preparation and filing of marketing applications for a biopharmaceutical product in US, EU, Japan, and ROW markets. The individual will work collaboratively and proactively within the CMC project team and across multiple functional areas to help develop the strategy, scope, and content of the CMC sections of the marketing applications. Position Responsibilities Provide guidance to functional area authors/reviewers with regards to submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global...read more

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