Regulatory Affairs Director/Senior Director, Therapeutics

1 week ago

Brisbane, California, United States Mammoth Biosciences Full time
Job Summary

Mammoth Biosciences is seeking a highly experienced Regulatory Affairs Director/Senior Director, Therapeutics to lead the regulatory activities of our growing CRISPR-based therapeutic programs. This role will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings.

Key Responsibilities
  • Regulatory Strategy and Planning: Develop and implement regulatory strategies for Mammoth's therapeutic pipeline, ensuring compliance with US and EU regulations.
  • Regulatory Interactions and Filings: Collaborate with regulatory agencies, consultants, and internal stakeholders to maintain regulatory knowledge and ensure timely submissions.
  • Regulatory Function Development: Build and lead a regulatory function for the company, overseeing the development of regulatory strategies and policies.
  • Regulatory Knowledge and Expertise: Maintain real-time understanding of regulatory requirements and guidelines, ensuring Mammoth's therapeutic candidates meet regulatory standards.
  • Regulatory Submissions and Communications: Develop and coordinate high-quality submissions for global clinical trials, ensuring compliance with regulatory requirements.
Requirements
  • Education: Bachelor's degree in life sciences or related field.
  • Experience: Minimum 10+ years of experience in the biotechnology and/or biopharmaceutical industry, with a minimum of 7 years in a Regulatory capacity.
  • Skills: Strong project management skills, drive for excellence, and proven track record with regulatory agencies.
  • Preferred Qualifications: Advanced degree in life sciences, creative problem-solving skills, and experience with gene therapy products regulatory requirements.
Benefits
  • Company-paid health, vision, and dental benefits.
  • Unlimited vacation and generous sick time.
  • Company-sponsored meals and snacks.
  • Wellness, caregiver, and ergonomics benefits.
  • 401(k) with company matching.

  • Regulatory Affairs Director/Senior Director, Therapeutics

    2 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Job SummaryMammoth Biosciences is seeking a highly experienced Director/Senior Director, Regulatory Affairs, Therapeutics to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.Key ResponsibilitiesLead, define and manage the strategic regulatory direction for Mammoth's pipelineEstablish the...

  • Director/Senior Director, Regulatory Strategy, Therapeutics

    7 days ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Job Summary:Mammoth Biosciences is seeking a highly experienced Director/Senior Director, Regulatory Affairs, Therapeutics to lead the regulatory activities of our growing CRISPR-based therapeutic programs. This role will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings.Key Responsibilities:Lead, define and manage...

  • Senior Director, Medical Affairs and Strategy

    7 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryWe are seeking a highly motivated and experienced Executive Director, Medical Affairs to join our team at Vera Therapeutics. This is a key leadership position that will play a critical role in the development and execution of our medical affairs strategy.Key ResponsibilitiesMedical Affairs Strategy: Develop and execute a comprehensive medical...

  • Senior Director, Global Pharmacovigilance

    7 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryVera Therapeutics is seeking a highly experienced Senior Director, Global Pharmacovigilance to lead our global drug safety and pharmacovigilance function. This role will be responsible for providing medical oversight and strategic leadership to ensure proactive and timely benefit-risk assessments of all safety data related to our portfolio of...

  • Senior Director, Global Pharmacovigilance

    4 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics is seeking a highly experienced and skilled Senior Director, Global Pharmacovigilance to join our team. As a key member of our Clinical Safety and Pharmacovigilance department, you will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function.Key ResponsibilitiesLead global...

  • Director, Pharmacovigilance and Risk Management

    7 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryVera Therapeutics is seeking a highly experienced and skilled Senior Director, Global Pharmacovigilance to join our team. As a key member of our Medical Affairs department, you will be responsible for providing medical oversight for the global drug safety and pharmacovigilance function to ensure proactive and timely benefit-risk assessments of all...

  • Clinical Research Director, Senior

    7 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Director, Clinical Research to lead the development of clinical research programs in nephrology, rheumatology, and infectious diseases at Vera Therapeutics.Key ResponsibilitiesLead Clinical Research Programs: Develop and execute clinical research strategies to advance Vera Therapeutics'...

  • Health Economics Director

    6 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics is seeking an experienced Health Economics Director to join our team. As a key member of our Medical Affairs and Clinical Research department, you will be responsible for generating real-world evidence and health economics comparative effectiveness research.Key Responsibilities:Develop and execute health economics strategies...

  • Director of Health Economics and Market Access

    6 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleWe are seeking an experienced Health Economics Director to join our team at Vera Therapeutics. As a key member of our Medical Affairs and Clinical Research team, you will be responsible for generating real-world evidence and health economics comparative effectiveness research to support our product development and commercialization efforts.Key...

  • Director of Health Economics and Outcomes Research

    6 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics is seeking an experienced Executive Director to lead our Health Economics and Outcomes Research (HEOR) efforts. As a key member of our Medical Affairs and Clinical Research team, you will be responsible for generating real-world evidence and health economics comparative effectiveness research to support our product development...

  • Executive Director, Health Economics and Outcomes Research

    6 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics is seeking an experienced Executive Director to lead our Health Economics and Outcomes Research (HEOR) efforts. As a key member of our Medical Affairs and Clinical Research team, you will be responsible for generating real-world evidence and health economics comparative effectiveness research to support our product development...

  • Senior Manager, Analytical Sciences Expert

    7 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About Vera TherapeuticsVera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.Job SummaryWe are seeking a Senior Manager, Analytical Sciences to join our...

  • Executive Director of Health Economics and Outcomes Research

    7 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job DescriptionJob Summary:The Executive Director of Health Economics and Outcomes Research will lead the development and execution of health economics and outcomes research strategies to support the commercialization of Vera Therapeutics' products. This role will be responsible for generating real-world evidence and health economics comparative...

  • Analytical Sciences Leadership Position

    6 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About Vera TherapeuticsVera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.Job SummaryWe are seeking a Senior Manager, Analytical Sciences to join our...

  • Vice President of Regulatory Strategy, Therapeutics

    2 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Mammoth Biosciences OPPORTUNITY Mammoth is seeking a Vice President of Regulatory Strategy, Therapeutics, to spearhead the regulatory initiatives of our expanding CRISPR-based therapeutic portfolio as we transition from innovative concepts to market-ready solutions. This pivotal role will entail overseeing all facets of regulatory strategy, engagement, and...

  • Director of Clinical Pharmacology and Pharmacometrics

    2 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryThe Executive Director of Clinical Pharmacology and Pharmacometrics will play a pivotal role in leading and overseeing the clinical pharmacology & pharmacometrics activities within our organization. This position will be responsible for providing scientific leadership and a collaborative working environment to advance drug candidates from IND...

  • Head of Bioanalytical Sciences

    2 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job OverviewPosition: Head of Bioanalytical SciencesLocation: RemoteCompany Overview:Vera Therapeutics (Nasdaq: VERA) is a pioneering biotechnology firm dedicated to the development of innovative therapies for severe immunological conditions. Our mission is to enhance treatment options that directly address the underlying causes of immunologic diseases,...

  • Executive Director, Health Economics Strategist

    1 week ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleVera Therapeutics, a leading biotechnology company, is seeking a highly skilled Executive Director, Health Economics Strategist to join our team. As a key member of our organization, you will play a crucial role in advancing our mission to develop innovative treatments for serious immunological diseases.Key ResponsibilitiesDevelop and execute...

  • Director of Human Resources Operations

    3 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job DescriptionJob Title: Director of Human Resources OperationsLocation: Not SpecifiedAbout Us:Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.We are...

  • Senior Manager, Analytical Sciences Expert

    4 days ago

    Brisbane, California, United States Vera Therapeutics Full time

    About the RoleWe are seeking a highly skilled Senior Manager, Analytical Sciences to join our experienced and collaborative team at Vera Therapeutics. This key position will play a critical role in managing method validation, method transfer, and stability programs, as well as supporting all aspects of Quality Control functions for antibody and fusion...