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The Senior Regulatory Affairs Manager serves as the primary point of contact for regulatory oversight and management throughout all phases of drug development. This role involves managing multidisciplinary teams and client interactions to ensure that key regulatory milestones and timelines are met. A significant aspect of this position is providing strategic regulatory advice to clients and offering training and mentoring to team members. The manager will oversee regulatory compliance, assist with regulatory submissions, and maintain support for FDA applications while collaborating with cross-functional teams and staying updated on regulations and industry trends.
