Associate Director, Regulatory Affairs CMC
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About The Position
Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Lead for one or more RA CMC development and/or globally marketed products and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts with responsibility for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Provides product strategy and direction to commercial and clinical teams. Facilitates risk identification & mitigation strategies. Oversee activities of junior regulatory personnel. Manage contractual and budgetary responsibilities with best business practices.
