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Fortvita Biologics · 1 day ago

Director / Sr Director of Regulatory Affairs Lead

United States

Full-time

Remote

Director/Executive

10+ years exp

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering. Fortvita is seeking a dynamic and experienced Director/ Sr Director of Regulatory Affairs to develop and implement global strategies to secure and maintain market approval for products globally, leading the Global Regulatory Team and ensuring compliance with regulatory requirements.

Biotechnology

Responsibilities

Leads the GRT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products

Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests

Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products

Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders

Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives

Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products

Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management

Qualification

Regulatory AffairsDrug DevelopmentGlobal Regulatory StrategyOncology ExperiencePharmaceutical Regulatory ActivitiesRisk AssessmentBusiness AcumenLeadershipCross-functional Collaboration