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.
Develop global or US regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs and company objectives. • Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities • Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions • Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed • Provide strategic direction (and content input) on US Labeling • Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result. • Foster positive relationships with FDA. • Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development and other functions key to the success of product development. • Interact routinely and will develop a strong team environment with colleagues throughout GRS Degree Requirements Ph.D., M.D., PharmD. , MS or commensurate experience Experience Requirements Significant experience in regulatory affairs (e.g. 3-5 years) Key Competency Requirements Required: • Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval. • Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology. • Direct experience in developing strategy and leading teams through interactions with FDA. • Extensive experience in initiating and conducting successful interactions within FDA.
• Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals 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. Travel
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.
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