Associate Director, CMC Regulatory Affairs

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 rich in diversity. 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 organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle.  Members of the organization develop global regulatory CMC strategies and partners 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 and 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 CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Responsibilities

Represent regulatory CMC on and/or lead matrix teams for biologics pipeline products through completion of post-marketing commitments and relevant lifecycle management projects driven by research.

• Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule arketing 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

Requirements

• Minimum BA/BS Degree

• 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy.

• Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for biologics.

• Knowledge of pharmaceutical development, including drug substance, 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 multi