Senior Director, Global Regulatory Sciences, CMC, Operations & Policy

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 & provides compliance documents to support Health Authority submissions. 

Position Summary

The Global Regulatory CMC Operations & Policy Senior Director will manage a team with responsibility for operational activities (e.g. regulatory information systems, compliance, LT meetings) related to Global Reg CMC.  The position will be a member of the Global Reg CMC LT.  The group will partner with stakeholders across functional areas to enhance business processes with an overall goal of increasing efficiency and ensuring initiatives are aligned with business priorities as they relate to GRS-CMC responsibilities.

The Global Regulatory CMC Operations & Policy Senior Director will also be responsible for driving CMC regulatory policy and mapping the internal and external regulatory landscape for adequate communication and advocacy.  He or she will ensure an informed development and implementation of appropriate and effective regulatory policies (e.g., health authority legislation, regulations, guidelines and other Health Authority documents, Trade associations position papers).  

In addition to information in the position summary, the GRS-CMC Operations Senior Director is responsible for the following

• Coordinate and provide oversight/guidance to develop and maintain appropriate procedural documents, white papers and guidelines within GRS-CMC

• Analyze and measure the effectiveness of existing business processes within the Global RegCMC department and identify opportunities to improve business practices and processes to maximize resources

• Work effectively with stakeholders to understand functional interdependencies, assess impact on effective processes, develop mutually agreed-upon optimized processes and drive key cross-functional initiatives and business imperatives

• Develop, implement, and maintain new business processes to optimize interactions with the Intercon regulatory teams, including supporting prioritization and visibility of planned regulatory systems.

• Coordinate updates to information and Knowledge Management tools to enhance collaboration and information sharing across the department. 

• Facilitate departmental communication strategy and preparation of announcements, communications and periodic newsletter, when needed.

• Identify opportunities to proactively engage on emerging scientific/regulatory strategies (both internally and externally) to shape and influence changes in the regulatory environment and assess potential impact on BMS business, regulatory strategy and/or product portfolio.

Experience Requirements

• Minimum BA/BS Degree

• Minimum 12 years spent in Regulatory CMC and minimum of 5 years in Reg CMC leadership

• Understanding of biologics, small molecules, devices, and cell therapy preferred

• Knowledge of CMC regulatory requirements during development and post-approval phases. 

• Ability to develop/maintain strong wo