At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.
The GRS-CMC Associate Director will lead a team of CMC regulatory professionals, setting priorities and overseeing the quality and timeliness of the team’s CMC submissions across multiple development and life-cycle management projects of varying priorities and complexities.
The Associate Director supports the growth and development of team members, represents GRS-CMC on cross-functional teams, serves as a credible, respected spokesperson in discussions with key stakeholders, and seeks opportunities for external regulatory engagement for themselves and members of their team.
The GRS-CMC Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support BMS products regarding: Clinical trial applications; New marketing applications; HA responses and background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director will serve as the primary interface between Global Regulatory Sciences (GRS) and Cell Therapy Development Operations (CTDO). The GRS-CMC Associate Director will assess manufacturing change controls for global impact and guide technical teams on practical aspects of global change management.
Duties/Responsibilities
Provide direction and set priorities for the Team, aligned to GRS-CMC and company strategy, and communicate strategic direction based on global regulatory guidelines and experience
Build and lead a diverse, high-performing Team through targeted recruitment, engagement, coaching, and mentoring
Manage and actively support the growth and development of direct reports and/or Team members
Proactively manage the Team to take advantage of unplanned opportunities and overcome unforeseen obstacles, with a focus on continuous improvement of processes and technology
Oversee the preparation of CMC submissions across the Team’s projects and review submissions prepared by Team members for clarity of both strategic and technical content, thoroughness, completeness, and timeliness
Represent GRS-CMC on cross-functional teams and, as delegated, on governance committees; serve as a credible, respected spokesperson in discussions with key stakeholders
Act as SME on assigned or agreed regulatory policy topics related to GRS priorities and, as agreed with management, engage externally to advance key regulatory positions; seek opportunities for external regulatory engagement for self and Team members
Actively participate in leadership or department meetings and, where the role has direct reports, in GRS and BMS people manager forums
· Ensure the Team completes training assignments within designated timeframes
· Represent regulatory CMC on and/or lead…