Regulatory Affairs Director

4 days ago

Brisbane, California, United States Annexon Bioscience Full time
Job Title: Director, Regulatory Affairs

At 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 Responsibilities:
  • Develop, coordinate, and execute regulatory strategies for new product development registrations.
  • Collaborate with internal stakeholders to generate regulatory submission plans and direct document development, review, and finalization.
  • Prepare and submit all sections of all filings to regulatory authorities, including IND, NDA, CTA, and MAA applications.
  • Provide leadership in creating and executing proactive global regulatory strategies for product development, approval, and registration.
  • Lead global regulatory submission preparations per plan with minimal to no supervision.
  • Responsible for obtaining approval, including negotiation with regulators in the US and ROW, with minimal to no supervision.
  • Build relationships and trust with key internal and external stakeholders and decision-makers.
  • Manage relationships with external consultants/CROs supporting development of study start-up.
  • Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion.
  • Participate as an active, engaged global team member on core projects and/or provide RA guidance/strategy to core team members.
Requirements:
  • PhD/PharmD with 7+ years' experience in Regulatory Affairs or BS/MS with 10+ years' experience.
  • Primary responsibility for coordinating the preparation of drafts, edits, review, and submission of regulatory dossiers in support of investigational and new drug applications.
  • Superior scientific writing skills for developing regulatory documents.
  • Possesses in-depth knowledge of FDA regulations, including CTD/eCTD, and requirements for investigational products, IND, and BLA submissions, with direct experience working with FDA.
  • Supports the department in generating regulatory strategies, providing leadership to multidisciplinary teams, while working with project teams and management to identify regulatory risks and ensure the earliest possible arrival.
  • Proven success in regulatory agency interactions, ensuring timely submissions, approvals, and effective management of submission timelines.
  • Possesses leadership skills and ability to interact with senior management, and to work with outside vendors and partner companies.
  • Must be a demonstrated self-starter and team player with strong interpersonal skills.
Preferred:
  • International regulatory experience (e.g., EU and/or Canada).
What We Offer:
  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities, and the ability to achieve a work-life balance.
  • We are located in Brisbane, CA, with shuttle service from BART, CalTrain, and the Ferry.
  • Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.

  • Regulatory Affairs Director

    4 days 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 days 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

    5 days 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

    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

    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

    5 days 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

    {"title": "Regulatory Affairs Director", "content": "Lead Regulatory Affairs for Therapeutic ProgramsMammoth 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,...

  • Regulatory Affairs Director

    2 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Job Title: Director/Senior Director, Regulatory Affairs, TherapeuticsAbout the Role: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. As a key member of our team, you will be responsible for coordinating all aspects...

  • Regulatory Affairs Director

    3 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

    3 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

    3 weeks ago

    Brisbane, California, United States Mammoth Biosciences Full time

    Job Title: Director/Senior Director, Regulatory Affairs, TherapeuticsMammoth 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 Responsibilities:Lead, define, and manage the...

  • Regulatory Affairs Director

    4 days 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 Mammoth Biosciences Full time

    Job Title: Director/Senior Director, Regulatory Affairs, TherapeuticsMammoth Biosciences is seeking a seasoned regulatory 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...

  • Regulatory Affairs Director

    17 hours 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 days 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

    4 days 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 days 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

    3 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...

  • Associate Director/Director, Drug Product Process Development

    2 weeks ago

    Brisbane, California, United States Tempest Therapeutics Full time

    Job SummaryTempest Therapeutics is seeking an experienced professional to lead the drug product technical development plan for all products in our pipeline. As Associate Director/Director, Drug Product Process Development, you will collaborate with cross-functional teams to ensure the development and manufacturing of high-quality drug products.Key...

  • Associate Director/Director, Drug Product Process Development

    2 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...