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Regulatory Strategy: Develop overall regulatory strategy for assigned programs. Provide regulatory leadership as the Global Regulatory Lead to program teams. Lead the Regulatory Strategy Subteam(s) in the development of global regulatory plans.
Regulatory Support: Provide regulatory support and contribute to strategies for approval and commercialization. Collaborate cross-functionally to provide regulatory guidance throughout the product lifecycle. Prepare regulatory submissions.
Regulatory Compliance: Author, coordinate, review, and execute submissions and responses to regulatory authorities. Maintain knowledge of the evolving global regulatory landscape. Assess the impact of new regulations/guidance.
BlueRock Therapeutics
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.