Director of Global Regulatory Strategy

vor 2 Monaten


Boudry District, Schweiz Bristol Myers Squibb Vollzeit
About the Role

Bristol Myers Squibb is seeking a highly skilled and experienced Director, Global Regulatory Lead to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of global regulatory strategies for our products.

Key Responsibilities
  • Lead the development and implementation of global regulatory strategies for our products, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to ensure alignment of regulatory strategies with business objectives.
  • Develop and maintain relationships with regulatory agencies, including the FDA, EMA, and other global health authorities.
  • Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports, and summary documents.
  • Lead the preparation of regulatory submissions, including INDs, NDAs, and MAAs.
  • Ensure compliance with regulatory requirements and industry standards, including GCP, GMP, and GLP.
  • Develop and implement training programs for regulatory staff to ensure compliance with regulatory requirements and industry standards.
Requirements
  • Ph.D., M.D., PharmD, MS, or BS in a relevant field.
  • Significant experience in regulatory affairs, including experience with global regulatory submissions and interactions with regulatory agencies.
  • Strong understanding of scientific content and complexities, including oncology drug development.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and regulatory agencies.
  • Ability to lead and manage teams, including experience with team development and leadership.
  • Strong analytical and problem-solving skills, with the ability to analyze complex data and develop effective solutions.
About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to delivering innovative medicines that address the most pressing medical needs of our time. Our company is built on a foundation of passion, innovation, urgency, accountability, inclusion, and integrity.

We are an equal opportunities employer and welcome applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees, and we strive to provide a work environment that is free from discrimination and harassment.

We are committed to ensuring that our employees have the resources and support they need to succeed in their roles. We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan and other benefits.



  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Director, Global Regulatory Lead to join our team at Bristol Myers Squibb. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of global regulatory strategies for our products.Key ResponsibilitiesLead the development and...

  • Global Regulatory Lead

    vor 2 Monaten


    Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleBristol Myers Squibb is seeking a highly skilled and experienced Director, Global Regulatory Lead to join our team. As a key member of our organization, you will be responsible for leading our global regulatory strategy and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement global regulatory strategies to...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    Job Title: Director, Global Regulatory LeadJob Summary: We are seeking a highly experienced and skilled Director, Global Regulatory Lead to join our team at Bristol Myers Squibb. As a key member of our global regulatory affairs team, you will be responsible for providing strategic regulatory guidance and support to our development teams, ensuring compliance...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Director, Global Regulatory Lead to join our team at Bristol Myers Squibb. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of global regulatory strategies for our products.Key ResponsibilitiesLead the development and...


  • Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleThe Market Access/HEOR GBDS Associate Director will play a critical role in providing statistical support to Market Access/HEOR activities. This includes partnering with HEOR and Market Access functions to identify and address potential data gaps, design, prepare, and interpret analyses and data presentations to successfully enable market...


  • Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Director, Regulatory Cmc

    vor 5 Monaten


    Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry, Schweiz Bristol Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleThe Associate Director Business Process Optimization & Systems is a critical member of the Cell Therapy External Manufacturing (ExM) organization, reporting directly to the Sr. Director Global Business Process & Supplier Digital Strategy.This role is responsible for driving business process improvement initiatives via global cross-functional...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleThe Associate Director of Financial Planning and Analysis is a critical member of the GPS Controllers team, responsible for supporting the overall GPS Legal Entity financial planning, analysis, and reporting. This role will collaborate with various GPS teams and corporate finance function to drive process standardization, simplification, and...


  • Boudry, Schweiz Bristol-Myers Squibb Vollzeit

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...