Director, Regulatory Strategy

4 weeks ago

South San Francisco, United States Alumis Inc. Full time

Alumis 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 individual to provide leadership and support to global regulatory activities to achieve Alumis’ strategic vision in obtaining worldwide approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow. This role will report to the Executive Director and Head of Regulatory Strategy.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Develop and implement regulatory strategies to facilitate the progress for assigned programs in all phases of development.
  • Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory approvals.
  • Lead interactions with regulatory agencies for assigned programs
  • Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs / MAAs.
  • Interact with Regulatory Affairs personnel within external service providers
  • Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.

     

    EDUCATION/EXPERIENCE/SKILLS:

    • Bachelors or advanced degree in a scientific discipline, with a minimum of 10 years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable.

       

      Knowledge/Skills/Abilities:

      • Direct experience with pharmaceutical regulatory submissions and product approvals, contributing to major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
      • Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
      • Experience leading regulatory agency interactions.
      • Demonstrated leadership and success in management of regulatory activities and previous experience in successfully leading assigned activities within cross-functional teams.
      • Experience in providing strategic advice on integrated regulatory development plans and life cycle management.
      • Excellent verbal and written communication skills.
      • Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
      • Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience a plus.
      • Previous experience in successfully leading assigned activities within cross-functional teams.
      • Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.


        Alumis Values 
        • We Elevate 
        • We Challenge 
        • We Nurture 

         

        This position is located in South San Francisco, CA. At this time we are not considering remote applicants.  

         

        The salary range for this position is $220,000 USD to $250,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. 

         

        Alumis Inc. is an equal opportunity employer. If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated. 

  • Regulatory Strategy Director

    5 days ago

    South San Francisco, California, United States Alumis Full time

    Job 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...

  • Director, Regulatory Strategy

    3 weeks ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis 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...

  • Director, Regulatory Strategy

    3 weeks ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Director, Regulatory Strategy

    1 month ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Director, Regulatory Strategy

    1 month ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis 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...

  • Regulatory Strategy Director

    3 days ago

    San Diego, California, United States Neurocrine Biosciences Full time

    About 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...

  • Fintech Regulatory Affairs and Strategy Director

    2 days ago

    San Francisco, California, United States The MENA Catalysts, Inc. Full time

    About 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...

  • Head of Regulatory Affairs Strategy

    1 week ago

    South San Francisco, California, United States Alumis Full time

    Position 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...

  • Head of Regulatory Affairs Strategy

    1 week ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewAlumis Inc. is a pioneering company dedicated to enhancing the lives of individuals affected by autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face significant challenges. Our mission is to fundamentally improve outcomes for these individuals. We are in...

  • Head of Regulatory Affairs Strategy

    2 weeks ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: $220,000 to $250,000 annuallyAlumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to profoundly alter the...

  • Head of Regulatory Affairs Strategy

    1 week ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc is dedicated to revolutionizing the treatment landscape for patients suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to dramatically improve patient outcomes. We are in...

  • Head of Regulatory Affairs Strategy

    1 week ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewAlumis Inc. is a pioneering company in precision medicine dedicated to improving 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 fundamentally enhance the outcomes for...

  • Head of Regulatory Affairs Strategy

    1 week ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewAlumis Inc is dedicated to revolutionizing the treatment landscape for patients grappling with autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous individuals with immunologic conditions still face significant challenges. Our objective is to fundamentally enhance patient outcomes. We are in search of...

  • Director of Regulatory Compliance

    5 days ago

    South San Francisco, California, United States Alumis Full time

    Job SummaryWe are seeking an experienced Regulatory Strategy Director to join our team at Alumis Inc. in South San Francisco, CA. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies to facilitate the progress of assigned programs in all phases of development.Key...

  • Executive Director, Regulatory Affairs

    4 days ago

    San Diego, United States Regulatory Affairs Professionals Society Full time

    Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

  • Executive Director, Regulatory Affairs

    5 days ago

    San Diego, United States Regulatory Affairs Professionals Society Full time

    Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...

  • Director of Regulatory Affairs

    4 weeks ago

    South San Francisco, United States Trebla Talent Full time

    Role:Director, Regulatory Affairs Bay Area/HybridCompany Description:This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working! Their innovative approach has already earned FDA...

  • Director of Regulatory Affairs

    4 weeks ago

    South San Francisco, United States Trebla Talent Full time

    Role:Director, Regulatory Affairs Bay Area/HybridCompany Description:This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working! Their innovative approach has already earned FDA...

  • Director of Regulatory Strategy

    3 months ago

    San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...

  • Director of Regulatory Strategy

    3 months ago

    San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...