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.

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