Senior Director, Regulatory Strategy

4 weeks ago


South Boston, United States Inozyme Pharma Full time

Senior Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton.Position Overview: As the Senior Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs.Responsibilities: Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.Develop and implement global regulatory strategies for rare disease therapeutic programs, ensuring alignment with corporate objectives and regulatory requirements.Provides advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etcMonitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs Proactively monitor and analyze regulatory trends, guidelines, and developments related to rare disease therapies, and provide strategic recommendations to senior management.Minimum of 10 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development.Proven track record of successfully leading regulatory strategy and submissions for rare disease therapeutic programs.



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