Associate Director Global Regulatory Sciences - Oncology

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. Associate Director, Global Regulatory Strategy, Hematology/Oncology Position Responsibilities as a Global and US Regulatory Lead * In conjunction with the Team leader; develop global regulatory strategy in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. * 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. * Work with cross-functional groups to define and manage contributions to 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. * Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines. * Participate in and/or lead regulatory interactions with FDA, as assigned. * In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans. Skills/Requirements * Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science). * 4-8 years pharmaceutical industry experience; significant experience in regulatory affairs (e.g. 3-5 years). * Thorough knowledge of the drug development process, IND and NDA process. Demonstrated experience in preparing FDA submissions. * Strong experience with US Regulatory submissions and dossiers (e.g., INDs; NDAs). * Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment. * Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance * Must be able to innovate, analyze and solve problems with minimal supervision and attention to details. * 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. * 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. * Experience applying project management techniques within teams. Experience in effectively managing meetings. * Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. * Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate. * Some travel may be required. If you...