Senior Manager, Oncology, Global Regulatory Strategy & Policy

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

  • In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across oncology.
  • Lead and/or support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.
  • Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRT.
  • Propose approaches to resolve regulatory issues and appropriately drive speed to patients.
  • Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities.
  • Lead the preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries
  • Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP, ) etc.
  • Understanding of scientific content, drug development and regulatory requirements.
  • Participate in the assessment of regulatory precedence and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g. registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom.
  • Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops.
  • Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).
  • Facilitate identification of and internal agreement on target labeling

Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience

At least 2-4 years of relevant regulatory experience or 4-8 years pharmaceutical industry experience.

  • A basic knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required.Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers within in a cross-functional environment. Proven ability to work with outside partners.
  • Demonstrated ability to be solution-oriented
  • Seeks multiple perspectives and listens openly to others’ points of views.
  • Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
  • Demonstrates ownership of results within (and beyond) area of responsibility.
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.

Looks for opportunities for continuous improvement.

Other Qualifications:
  • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.
  • Communicates opinions, facts and thoughts with clarity, transparency and honesty
  • Demonstrates ownership of results within (and beyond) area of responsibility.
  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
  • Looks for opportunities for continuous improvement.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.