Director, Regulatory CMC - Cell Therapy

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. The GRS-CMC Director is responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross functional teams, governance committees, and due diligence /in-licensing projects. Represent BMS at Health Authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team. Duties/Responsibilities: * Develop and communicate strategic direction based on global regulatory guidelines and experience * Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness * Review submissions from CMC Leads for clarity of both strategic and technical content * Utilize electronic systems for dossier creation, review, and tracking * Manage and actively support growth and development of direct reports * Actively participates in leadership or department meetings * Anticipate and communicate possible regulatory paradigm shifts * Participate in product fact finding meetings and/or R&D forums representing GRS-CMC * Support the preparation of CMC policies and procedures * Ensure Regulatory Compliance: Maintain oversight and promote the highest standards of regulatory compliance by actively monitoring and verifying timely and accurate data entry into the Regulatory Information Management system within designated timeframes Qualifications: Qualifications * Minimum BA/BS Degree * Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8+ years regulatory CMC experience Key Competencies: * Knowledge of CMC regulatory requirements for advanced therapies and/or and cell therapy during development and post-approval as applicable * Knowledge of pharmaceutical development, including advanced therapies and/ or, biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products as applicable * Ability to develop/maintain strong working relationships, participate in and/or lead multifunctional teams, handle and prioritize multiple projects and work independently * Ability to interact with CMC technical experts regarding technical issues such as those related to process development and analytical * Understanding of scientific content and complexities and good knowledge of drug development with proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration * Experience leading cross-functional teams, demonstrated ability to drive quality decision-making and ability to organize / prioritize tasks * Demonstrated ability to negotiate with and influence others and to facilitate issue resolution and conflict management * Direct experience in developing strategy and leading teams through...