Regulatory Affairs Director, Precision Medicine
- Summit, 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.
Director, Regulatory Affairs
Executive Director, Regulatory Affairs
Global Regulatory Affairs
- Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
- Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.
- Ensure global regulatory plans support a precision medicine approach e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.
- Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists and collaborates in strategic meetings with health authorities.
- Represents BMS in key interactions with Health Authorities
- Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products.
- Ensure high quality collaboration with Precision Medicine team to development of biomarker, companion diagnostic and other device to optimize access to patients.
- Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.
- Provides guidance on planning, writing, review of key dossier documents for submissions globally.
- Ensure Global Regulatory Science and Policy representation as needed in governance or strategic teams or committees.
- To ensure compliance of BMS programs with regulatory requirements for diagnostics and devices.
- Provides ongoing feedback and accountable for coaching, and career development to staff in order to maximize their potential.
- Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
- Significant experience in regulatory affairs and diagnostic related development (e.g. > 8-10 years)
- Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals
- Extensive experience developing companion diagnostics and devices.
- Experience of drug development and drug regulatory procedures.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
- Experience and understanding of digital health platforms preferred.
- Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for diagnostic development and approval.
- Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
- Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
- Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
- Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
- Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
- Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
- Experience utilizing leadership techniques to drive a team through the stages of team development.
- Proven ability to coach and mentor other leaders as a coach, while being an individual contributor to projects.
- Successful track record of leading through influence and working across complex, global organizational matrices.
- 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
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
- 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.
- 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.
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