Job Description

Associate Director, Global Regulator Strategy, Neuroscience

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.

Position Summary

The selected candidate will have leadership responsibility for global regulatory strategy within a development team. Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers.

Position Responsibilities

• Support the preparation of, and participate in / lead key HA interactions. Assure consistent positions on common issues are presented to global HA.
• Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans
• Develop target labeling and co-lead the cross-functional labeling team.
• Ensure consistent positions are presented in responses to global health authority queries.
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input.
• In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
• Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application queries on new protocols and protocol amendments in compliance with HA deadlines.

Education / Experience Requirements

• Bachelor's degree required; advanced scientific degree preferred with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.

Key Competency Requirements

• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
• Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
• Understanding of scientific content and complexities and good knowledge of drug development is desired.
• Experience in successfully leading teams; Demonstrated ability to drive quality decision-making.
• Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
• Direct experience in developing strategy and leading teams through interactions with health authorities.
• Demonstrated ability to negotiate with and influence others.
• Ability to facilitate issue resolution and conflict management.
• 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.
• Experience as a member of GRTs, project working groups, or comparable experience.

Additional 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.
• 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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

Bristol Myers Squibb is an equal opportunity employer and welcomes applications from diverse candidates.

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