Associate Director, Regulatory Strategy, Cardiovascular, Global Regulatory Strategy & Policy
- Princeton, NJ
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.
Expected areas of competence
- In partnership with the global regulatory strategist and regional strategists/liaisons develop strategic and operational plan for the development and the registration of assets across CFIG.
- Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies.
- Propose innovative approaches to resolve complex regulatory issues and appropriately drive speed to patients.
- Define innovative objectives for global health authority interactions and underlying strategic plan. Contribute to building a strong and trusted relationship with Health Authorities.
- Diverse experience in regulatory activities in support for development goals.
- Understanding of scientific content and complexities.
- Proven flexibility in adapting to new therapeutic areas and partnering with outside and internal experts.
- Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities).
- Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, eg 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.
- Facilitate identification of and internal agreement on optimal target labeling
- Demonstrated ability to break down complex, scientific content into logical components.
- Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners.
- Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting
- Generates alternative regulatory strategies and plans, and assesses benefits and risks.
- Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources.
- Creates a unified and seamless team using both internal and external resources to execute regulatory strategy
- Communicates opinions, facts and thoughts with clarity, transparency and honesty
- 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.
- Develops and applies unique ideas and new methods to achieve higher performance and excellence.
- Works across organizational, functional and geographic boundaries to achieve company goals.
- Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.
- Demonstrates resilience and perseverance.
- Solid scientific background, Ph.D., M.D., PharmD or equivalent professional experience with at least 7 years of relevant regulatory 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.
- Excellent track records on BMS behaviors.
- Demonstrated ability to be solution-oriented and drive fast yet quality decision-making.
- Ability to communicate issues and risks clearly in written and verbal format to teams and management.
- Proven success in negotiating regulatory objectives with HA
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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