Director, Regulatory CMC - Cell Therapy

Director, Regulatory CMC - Cell Therapy Overview Responsible for overseeing management of multiple development and life-cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross-functional teams and governance committees, and at Health Authority meetings. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seek opportunities for external regulatory engagement for themselves and/or team members. Duties/Responsibilities: Develop and communicate strategic direction based on global regulatory guidelines and experience Prepare or oversee preparation of CMC submissions 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 participate 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 Manage relationships with diverse teams Support the preparation of CMC policies and procedures Ensure regulatory compliance: monitor and verify timely and accurate data entry into the Regulatory Information Management system within designated timeframes Qualifications: Minimum BA/BS Degree Minimum 10 years pharmaceutical or related experience, with 8+ years regulatory CMC experience; multidiscipline experience preferred Key Competencies: Knowledge of CMC regulatory requirements for advanced therapies and/or cell therapy during development and post-approval as applicable Knowledge of pharmaceutical development, including advanced therapies, biologics, and cell therapy processes, analytical methods, and products Ability to develop/maintain strong working relationships; lead multifunctional teams; manage multiple projects; work independently Ability to interact with CMC technical experts on process development and analytical topics Understanding of scientific content and drug development with global regulatory strategies aligned with clinical plans and marketing objectives Experience leading cross-functional teams; ability to drive quality decisions and prioritize tasks Negotiation and conflict-resolution skills; ability to influence others Experience developing strategy and leading teams through health authority interactions Strong understanding of global regulatory policy, laws, and guidelines for drug development and approval Interpersonal skills and a mindset for continuous improvement; cross-functional collaboration Ability to communicate regulatory strategy, issues, and risks to senior leadership and governing bodies Experience as a CMC Team member or in related groups; experience with product partnerships (out-licensing, divestiture, co-development, in-licensing, acquisitions) Ability to represent department functions in a matrix organization Seeks multiple perspectives and considers diverse viewpoints Prior management experience preferred Proficient with electronic systems Travel up to 5% Note: This description reflects current expectations for the role and may be subject to change. All legal requirements and company policies apply. #J-18808-Ljbffr Bristol Myers Squibb EU Policy