Senior Director, Regulatory Strategy
4 weeks ago
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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Boston, United States BioSpace, Inc. Full timeJob Details Company Overview: Inozyme Pharma,Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical companydeveloping novel therapeutics for the treatment of diseases of abnormalmineralization impacting the vasculature, soft tissue, and skeleton. Throughour in-depth understanding of the biological pathways involved inmineralization, we are...
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Senior Manager Regulatory Affairs, Strategy
3 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate 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. Through our in-depth understanding of the...
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Senior Manager Regulatory Affairs, Strategy
4 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory StrategyCompany 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. Through our in-depth understanding of the biological...
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Senior Manager Regulatory Affairs, Strategy
4 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory StrategyCompany 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. Through our in-depth understanding of the biological...
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Senior Director, Regulatory Affairs
3 weeks ago
Boston, Massachusetts, United States Proclinical Full timeSenior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...
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Regulatory CMC Director
14 hours ago
Boston, United States Dennis Partners Full timeOur client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC,...
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Senior Director, Regulatory Affairs
4 weeks ago
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
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Director/Assoc Director Regulatory Affairs
4 weeks ago
Boston, United States Apex Systems Full timeJob#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location: Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...
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Senior Director of People and Culture
1 week ago
Boston, United States Taylor Strategy Partners Full timeDescription Senior Director of People and Culture The Director of People and Culture is responsible for managing and leading a company’s human resources and organizational culture functions. Some specific duties and responsibilities may include: Responsibilities Develop and implement HR policies and procedures Managing employee relations and resolving...
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Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Foundation Medicine Full timeAbout the JobThe Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...
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Director, Strategy
2 weeks ago
Boston, United States Fidelity TalentSource LLC Full timeJob Description:The RoleThe Director, Strategy is a member of the Fidelity Institutional WealthManagement Services (IWMS) organization and will play a key role in the ongoing development of the IWMS strategy and long-term plan. In this role you will drive day-to-day management and leadership of key cross-Fidelity Brokerage Operations and Technology (FBOT)...
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Boston, United States Fidelity TalentSource LLC Full timeJob Description:The RoleThe Director of Product Disclosure Policy and Regulatory Strategy is responsible for establishing and administering guidelines for the dissemination of portfolio holdings information across Fidelity s retail and institutional product lines and will also play an integral role in establishing and maintaining Fidelity Fund Investment...
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Director, Regulatory Affairs
1 week ago
South San Francisco, United States Maze Therapeutics Full timeThe Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...
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Senior Director, CMC Regulatory Affairs
4 weeks ago
South San Francisco, United States Allogene Therapeutics Full timeJob Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...
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Director, Regulatory Affairs
2 weeks ago
South San Francisco, California, United States Maze Therapeutics Full timeThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...
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Director, Regulatory Affairs
2 weeks ago
South San Francisco, United States Maze Therapeutics Full timeJob DescriptionJob DescriptionThe Position:Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global...
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Director, Global Regulatory Lead
4 weeks ago
Boston, Massachusetts, United States AbbVie Full timeJob Description The Director, Global Regulatory Lead, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global...
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Director, Regulatory Affairs
7 days ago
Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Director, Regulatory Affairs
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Americas Director of Marketing
4 weeks ago
Boston, United States Roland Berger Strategy Consultants Full timeJob Description At its core, Roland Berger is defined by its people. In order to successfully support clients and grow business, the firm must continually attract the best and the brightest talent and create an outstanding team of consulting professionals in a dynamic, vibrant, thriving environment. The Americas Director of Marketing will be responsible for...