Director, Regulatory Strategist, Global Regulatory Affairs

Bristol Myers Squibb•Madison, WI

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement. Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters Provide strategic regulatory input on the target product profile, CCDS, and country-specific label Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions Formulate US regulatory strategy and filings Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors Approval of regulatory documents Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines Behaviors 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.

Requirements

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
Significant experience in regulatory affairs (e.g. > 4-7 years)
Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
Experience leading cross functional matrix teams
Demonstrated ability to break down complex, scientific issue and communicating regulatory implications
Proven success in negotiating regulatory objectives with HA

Responsibilities

Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.
Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans
Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed
Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders
Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources
Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies
Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters
Provide strategic regulatory input on the target product profile, CCDS, and country-specific label
Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions
Formulate US regulatory strategy and filings
Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors
Approval of regulatory documents
Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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