Associate Director, GRS-CMC Biologics

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The CMC Regulatory Associate Director is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biotechnology products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); &/or post-approval submissions. In this role, the GRS-CMC Associate Director will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Global Product Supply (GPS). The GRS-CMC Associate Director will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.

Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for biotechnology pipeline products and/or commercial products through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions.
• Independently provide strategic guidance/input related to current regulatory requirements and expectation for marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
• Independently manage and prioritize multiple complex projects
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
• Identify, communicate and propose resolutions to routine/complex issues
• Interpret global regulations and guidance. Identify regulatory opportunity and risks.
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings
• Review and provide regulatory assessments on change controls
• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
• Mange relationships with diverse teams
• Utilize electronic systems for dossier creation and tracking.

Qualifications

• 7-10+ years Pharmaceutical industry experience – prefer knowledge of biotechnology products, including multi-disciplined experience, 6+ years CMC regulatory strategy experience.
• Knowledge of CMC regulatory requirements during development and post-approval.
• Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods.
• Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
• Ability to identify, communicate and resolve complex issues.
• Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
• Ability to interpret global regulations and guidance.

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 the resources to pursue their goals, both at work and in their personal lives.