Regulatory Strategy Director
5 hours ago
Job Summary:
Cypress HCM is seeking a highly skilled and experienced Regulatory Strategy Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing global regulatory oversight and project leadership for assigned development products.
Key Responsibilities:
- Regulatory Strategy and Planning: Develop and execute global regulatory strategies for expedited product development across one or more programs, ensuring alignment with overall corporate objectives.
- Regulatory Communications: Oversee regulatory communications with health authorities, ensuring seamless integration of regulatory plans and strategies.
- Regulatory Lifecycle Management: Manage the global regulatory lifecycle of assigned investigational products, coordinating submission content and timelines.
- Regulatory Research and Analysis: Research regulatory precedents and emerging trends for development risks and opportunities, providing insights to inform business decisions.
- Team Leadership: Lead milestone development meetings, prepare the team for engagements, and review and communicate current regulatory requirements for compliance with US and international regulations.
- Regulatory Operations: Interface with the external Regulatory Operations group for document compilation and e-submission, ensuring timely and accurate submissions.
- Regulatory Compliance: Contribute to the development and review of standard operating procedures (SOPs), ensuring adherence to regulatory requirements.
- Regulatory Monitoring: Monitor the company's progress in meeting regulatory commitments, identifying areas for improvement and implementing corrective actions.
Requirements:
- Education: Bachelor's degree in life sciences; advanced degree preferred; Regulatory Affairs Certification a plus.
- Experience: Strong pharmaceutical Regulatory Affairs experience with a focus on drug/biologics development, including direct experience in preparing, submitting, and managing global investigational/marketing applications in eCTD format.
- Skills: In-depth knowledge of GXP/ICH guidelines and global regulations, ability to interpret and apply complex regulatory guidance, strong written and verbal communication, analytical, organizational, and interpersonal skills.
- Leadership: Excellent strategic planning and cross-functional project management skills, ability to thrive in a dynamic environment with flexibility.
Compensation:
$165-225K
-
Regulatory Strategy Director
6 days ago
San Diego, California, United States Neurocrine Biosciences Full timeAbout the RoleWe are seeking a highly experienced and skilled Regulatory Strategy Director to join our team at Neurocrine Biosciences. As a key member of our regulatory affairs team, you will be responsible for leading and managing regulatory activities for assigned commercial and/or development products.Key ResponsibilitiesDevelop and implement global...
-
Regulatory Strategy Director
1 week ago
South San Francisco, California, United States Alumis Full timeJob SummaryWe are seeking a highly motivated and experienced Regulatory Strategy Director to join our team at Alumis Inc. in South San Francisco, CA. As a key member of our project teams, you will provide leadership and support to global regulatory activities to achieve Alumis' strategic vision in obtaining worldwide approvals to market our products.Key...
-
Regulatory Affairs Director
1 week ago
San Diego, California, United States Modular Medical Inc Full timeJob Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...
-
Director of Regulatory Compliance
1 week ago
San Diego, California, United States Modular Medical Inc Full timeJob Description**Job Title:** Director of Regulatory Affairs**Job Category:** Exempt**Department:** R&D**Direct Report:** N/A**Location:** N/A**Travel Required:** N/A**Salary Range:** N/A**Position Type:** Full-time/OnsiteJob SummaryModular Medical Inc is seeking a highly experienced Director of Regulatory Affairs to lead our regulatory strategy and ensure...
-
Head of Regulatory Affairs Strategy
2 weeks ago
San Diego, California, United States Cypress HCM Full timeExciting Opportunity in Regulatory AffairsAre you an experienced professional with a strong background in global regulatory management and project execution? As a pivotal member of Cypress HCM, you will be instrumental in advancing our objectives within the pharmaceutical sector. In the role of Regulatory Affairs Director, you will be responsible for...
-
Director, Regulatory Strategy
1 month ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motivated...
-
Senior Vice President of Regulatory Strategy
2 weeks ago
San Diego, California, United States Travere Therapeutics Full timeDirector of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a dedicated team committed to transforming the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our remarkable workforce is crucial to our achievements. We are a passionate group focused on addressing the distinct needs of patients...
-
Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Codera Full timeJob DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...
-
Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Codera Full timeJob DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...
-
San Francisco, California, United States The MENA Catalysts, Inc. Full timeAbout The MENA Catalysts, Inc.The MENA Catalysts, Inc. is a government relations strategy firm specializing in fintech and crypto multinationals. We are seeking a senior director to lead our fintech legislative and regulatory affairs efforts for global clients expanding in the Middle Eastern economies.Key ResponsibilitiesRegulatory Strategy...
-
Regulatory Affairs Director
4 days ago
San Diego, California, United States Tbwa ChiatDay Inc Full timeJob SummaryWe are seeking a highly experienced Regulatory Affairs Director or Senior Regulatory Affairs Director to join our team at Kura Oncology. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with governing laws, regulations, and internal policies and procedures.Key ResponsibilitiesEnsure U.S....
-
Regulatory Strategy Director
7 hours ago
South San Francisco, California, United States Alumis Full timeJob Description**About Alumis**Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.**Job Summary**We are seeking an exceptionally motivated individual to provide leadership and support to global regulatory activities to...
-
Head of Regulatory Affairs Strategy
2 weeks ago
San Diego, California, United States Cypress HCM Full timeStrategic Role in Regulatory AffairsAre you an experienced professional with a strong interest in international regulatory management and project oversight? As a key player in the pharmaceutical sector, you will assume a vital position in steering the development of innovative products while ensuring adherence to local and global regulations.Key...
-
San Diego, California, United States International Staff Consulting Full timeJob SummaryWe are seeking an experienced Executive Director, Toxicology to join our team at International Staff Consulting. This is a key leadership role that will oversee the activities of our Toxicology group and provide strategic direction to ensure the successful execution of toxicology studies.Key ResponsibilitiesProvide leadership and oversight to the...
-
San Diego, California, United States Travere Therapeutics Full timeJob SummaryWe are seeking a highly experienced and skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. This is a key leadership role that will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.Key...
-
San Diego, California, United States Travere Therapeutics Full timeJob SummaryWe are seeking a highly experienced and skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. As a key member of our Regulatory Affairs department, you will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.Key...
-
Regulatory Strategy Coordinator
2 weeks ago
San Diego, California, United States Jobot Full timePosition OverviewJoin Jobot, a leader in water resources engineering, as a Regulatory Policy Specialist. In this role, you will be responsible for crafting and executing regulatory frameworks pertaining to water management and stormwater systems.Key ResponsibilitiesCollaborate with cross-functional teams to ensure adherence to environmental...
-
Regulatory Affairs and Compliance Lead
1 week ago
San Diego, California, United States ORIC Pharmaceuticals, Inc. Full timeJob SummaryORIC Pharmaceuticals, Inc. is seeking a highly motivated and experienced Director/Associate Director to lead our Regulatory Affairs and Compliance team. As a key member of our organization, you will be responsible for ensuring compliance with global regulatory requirements and developing strategies to support our clinical development programs.Key...
-
San Diego, California, United States Artiva Biotherapeutics Full timeJob SummaryWe are seeking a highly experienced Senior Director to lead our Clinical Operations and Strategy team at Artiva Biotherapeutics. As a key member of our clinical team, you will be responsible for overseeing the execution of clinical trials, managing vendor relationships, and driving operational excellence.Key ResponsibilitiesDevelop and implement...
-
Head of Regulatory Affairs Strategy
2 weeks ago
South San Francisco, California, United States Alumis Full timePosition OverviewSalary: $220,000 to $250,000 annuallyAlumis Inc. is a pioneering company in precision medicine, dedicated to enhancing the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to...
