Bristol Myers Squibb
Hyderabad, Telangana, India Posted 2d ago
Bristol Myers Squibb is seeking an Associate Director for GRS-CMC cell therapy to provide regulatory expertise related to CMC activities through all stages of a product's lifecycle and lead a team of CMC regulatory professionals.
Key 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 engage externally to advance key regulatory positions.
Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversight from supervisor on complex topics.
Requirements
Minimum BA/BS Degree
8+ years Pharmaceutical industry experience – prefer knowledge of biotechnology or cell therapy products, including multi-disciplined experience, with 5+ years in CMC regulatory strategy.
Prior people management or team leadership experience preferred; experience coaching, mentoring, and developing team members.
Knowledge of CMC regulatory requirements for advanced therapies, biologics, and cell therapy during development and post-approval as applicable.
Knowledge of pharmaceutical development, including advanced therapies, biologic, and cell therapy upstream and downstream processes, analytical methods, and biologic/device combination.
Experience communicating regulatory strategy, issues, and risks, in written and verbal format, to regulatory senior leadership and other governing bodies.
