Senior Director, Regulatory Strategy
Found in: beBee S US - 1 week 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, etc
- Monitors 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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Senior Director, Regulatory Strategy
Found in: beBee jobs US - 2 weeks ago
South Boston, United States Inozyme Pharma Full timeSenior 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...
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Senior Manager Regulatory Affairs, Strategy
3 days 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 days 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
7 days 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
5 days 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
Found in: Appcast US C2 - 1 week 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
Found in: Appcast Linkedin GBL C2 - 1 week 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
Found in: beBee jobs US - 2 days 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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Sr. Director Regulatory Affairs
1 week ago
South San Francisco, United States Life Science People Full timeSenior Director of Regulatory Affairs Menlo Park, CA Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. My client is looking for someone to come in and lead their regulatory efforts in oncology as they pioneer cortisol modulation...
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Sr. Director Regulatory Affairs
5 days ago
South San Francisco, United States Life Science People Full timeSenior Director of Regulatory Affairs Menlo Park, CA Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. My client is looking for someone to come in and lead their regulatory efforts in oncology as they pioneer cortisol modulation...
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Regulatory CMC Director or Associate Director
Found in: Jooble US O C2 - 2 weeks ago
Boston, MA, United States Dennis Partners Full timeThey are seeking a Regulatory CMC Director or Associate 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, you will work closely with cross-functional teams, CMOs, and Health Authorities. This company...
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Sr. Director Regulatory Affairs
Found in: Appcast US C2 - 2 weeks ago
South San Francisco, United States Life Science People Full timeSenior Director of Regulatory AffairsMenlo Park, CA Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. My client is looking for someone to come in and lead their regulatory efforts in oncology as they pioneer cortisol modulation...
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Sr. Director Regulatory Affairs
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
South San Francisco, United States Life Science People Full timeSenior Director of Regulatory AffairsMenlo Park, CA Life Science People are currently working with an exciting client, looking for a Sr. Director Regulatory Affairs professional with a strong background in oncology submissions. My client is looking for someone to come in and lead their regulatory efforts in oncology as they pioneer cortisol modulation...
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Senior Director, Regulatory Affairs
2 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
Found in: Talent US C2 - 2 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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Boston, United States Scorpion Therapeutics Full timeScorpion Therapeutics is seeking an experienced Regulatory Strategist to lead strategic planning and execute regulatory plans of early oncology assets from first-in-human to commercialization. Reporting to the Head of Regulatory Affairs and Quality. Have overall responsibility in creating and harmonizing global clinical trial execution, achieving regulatory...
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Senior Director, Regulatory Project
Found in: Jooble US O C2 - 2 weeks ago
Boston, MA, United States Peacefestival Full timeSenior Director, Regulatory Project & Submission Management Opportunities for Senior Director, Regulatory Project & Submission Management in Boston, MA Remote positions only Search completed. Found 0 matching records. Opportunities for Senior Director, Regulatory Project & Submission Management in Boston, MA Remote positions only Search...
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Senior Director, Regulatory Affairs
Found in: Jooble US O C2 - 2 weeks ago
Boston, MA, United States Hillevax 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...
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Regulatory Affairs Director
1 week ago
Boston, United States Disability Solutions Full timeAbout the Job The 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,...
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Senior Director, CMC Regulatory Affairs
1 week 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...