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Senior Consultant, Regulatory Affairs - FDA Regulated Products (Remote)
Professional Excellence Develop regulatory strategy for projects including creative solutions to complex problems Knowledge of current regulations, laws and guidance both US and ex-US Ability to take a leadership position on project teams and drive the project to completion as the project manager Ability to manage several projects at different stages of development Independent planning, coordination and preparation of document packages for regulatory submissions, such as meeting requests and briefing packages to support meetings with regulatory agencies, INDs/CTAs, and NDA/BLA/MAAs Knowledge of eCTD format Independently initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, up


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