Current jobs related to Regulatory Affairs Director/Senior Director, Therapeutics - Brisbane, California - Mammoth Biosciences

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Job Title: Director/Senior Director, Regulatory Affairs, TherapeuticsMammoth Biosciences is seeking a highly experienced and skilled 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,...

  • Regulatory Affairs Director

    2 months ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Job Title: Director/Senior Director, Regulatory Affairs, TherapeuticsMammoth Biosciences is seeking a highly experienced and skilled 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,...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Lead Regulatory Affairs for Therapeutic ProgramsMammoth Biosciences is seeking a seasoned Regulatory Affairs professional to lead the regulatory activities of our growing CRISPR-based therapeutic programs. As Director/Senior Director, Regulatory Affairs, Therapeutics, you will be responsible for coordinating all aspects of regulatory strategy, interactions,...

  • Regulatory Affairs Director Therapeutics

    3 weeks ago

    Brisbane, California, United States BioSpace, Inc. Full time

    Job SummaryMammoth Biosciences is seeking a highly experienced Regulatory Affairs 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. The ideal candidate will have a strong background in...

  • Regulatory Affairs Director

    3 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Mammoth BiosciencesOPPORTUNITYMammoth 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. This role will be responsible for coordinating all aspects of regulatory strategy,...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States BioSpace, Inc. Full time

    Job Title: Director, Regulatory AffairsAt BioSpace, Inc., we are seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for managing regulatory activities that support our company's projects and programs.Key Responsibilities:Develop and execute...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States Annexon Bioscience Full time

    Job Title: Director, Regulatory AffairsAt Annexon Biosciences, we are seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for managing regulatory activities that support our department and company projects and programs.Key...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States Annexon Bioscience Full time

    Job Title: Director, Regulatory AffairsAt Annexon Biosciences, we are seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for managing regulatory activities that support our department and company projects and programs.Key...

  • Regulatory Affairs Director

    3 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Mammoth Biosciences OPPORTUNITYMammoth Biosciences is seeking a highly experienced Regulatory Affairs Director 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. The Director will oversee and partner with several...

  • Regulatory Affairs Director

    3 weeks ago

    Brisbane, California, United States BioSpace, Inc. Full time

    Job DetailsCompany OverviewAt Annexon Biosciences, we are a biopharmaceutical company dedicated to advancing novel therapies for devastating classical complement-mediated neuroinflammatory diseases. Our scientific approach targets upstream C1q to block the classical complement inflammatory cascade, and our therapeutic candidates are designed to provide...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Annexon Biosciences. As a key member of our regulatory team, you will be responsible for managing regulatory activities that support our department and projects. This role will assist with leading, developing, coordinating, and executing regulatory...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States BioSpace, Inc. Full time

    Job DetailsOpportunity OverviewMammoth Biosciences is seeking a highly experienced Regulatory Affairs Director 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. The successful candidate will oversee and partner with...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Lead Regulatory Affairs for Therapeutic DevelopmentMammoth Biosciences is seeking a seasoned Regulatory Affairs professional to lead the development of our CRISPR-based therapeutic programs. As a key member of our team, you will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. This is a leadership position that...

  • Regulatory Affairs Director

    3 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Lead Regulatory Affairs for Therapeutic ProgramsMammoth Biosciences is seeking a seasoned Regulatory Affairs professional to lead the regulatory activities of our growing CRISPR-based therapeutic programs. As a key member of our team, you will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. This leadership role...

  • Regulatory Affairs Director

    4 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Lead Regulatory Affairs for Therapeutic ProgramsMammoth Biosciences is seeking a seasoned Regulatory Affairs professional to lead the regulatory activities of our growing CRISPR-based therapeutic programs. As a key member of our team, you will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. This leadership role...

  • Associate Director/Director, Drug Product Process Development

    4 weeks ago

    Brisbane, California, United States Tempest Therapeutics Full time

    Job SummaryWe are seeking an experienced professional to lead our drug product technical development plan for all products in our pipeline. As Associate Director/Director, Drug Product Process Development, you will be responsible for collaborating with cross-functional teams to ensure the development of high-quality drug products.Key...

  • Associate Director, Quality Assurance

    3 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job DescriptionJob Title: Associate Director, Quality AssuranceLocation: 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 to change the standard of care for patients.Position Summary:We...

  • Associate Director, Quality Assurance

    4 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job SummaryVera Therapeutics is seeking a highly experienced Associate Director, Quality Assurance to oversee the quality assurance for biologic/device combination product projects from inception to commercialization. The ideal candidate will have a strong background in drug delivery systems and medical device regulations.Key Responsibilities:Oversee the...

  • Executive Director, Clinical Pharmacology and Pharmacometrics Lead

    3 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job DescriptionRole SummaryVera Therapeutics is seeking a highly skilled Executive Director, Clinical Pharmacology and Pharmacometrics to lead and oversee clinical pharmacology & pharmacometrics activities within our organization. This role will play a crucial part in advancing drug candidates from IND through Phase IV.Key ResponsibilitiesDevelop and...

  • Associate Director, Clinical Operations

    4 weeks ago

    Brisbane, California, United States Vera Therapeutics Full time

    Job Title: Associate Director, Clinical OperationsAt Vera Therapeutics, we are seeking an experienced Associate Director, Clinical Operations to join our team. As a key member of our Clinical Operations department, you will be responsible for leading the management of clinical trials, including leadership and oversight of clinical operations staff and...

Regulatory Affairs Director/Senior Director, Therapeutics

2 months ago

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

Mammoth Biosciences is seeking a highly experienced Regulatory Affairs Director/Senior Director 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 pipeline, ensuring compliance with US and EU regulations.
  • Regulatory Interactions and Filings: Interface with regulatory agencies, prepare and submit high-quality regulatory filings, and maintain real-time understanding of regulatory requirements.
  • Collaboration and Leadership: Collaborate with cross-functional teams, including clinical, CMC, and nonclinical research, to ensure regulatory knowledge and compliance.
  • Regulatory Knowledge and Expertise: Maintain up-to-date knowledge of regulatory requirements, guidelines, and policies, and apply this expertise to drive regulatory strategy and decision-making.
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, ability to work in a fast-paced environment, and excellent communication and interpersonal skills.
Preferred Qualifications
  • Advanced Degree: Master's or PhD in life sciences or related field.
  • Regulatory Expertise: Proven track record of regulatory expertise, including experience with US and EU regulatory submissions.
Benefits
  • Competitive Salary: $205,000 - $260,000 per year, depending on experience.
  • Benefits Package: Comprehensive benefits package, including health, vision, and dental insurance, 401(k) matching, and generous vacation time.