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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 working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently. 

• Ability to interact with CMC technical experts regarding process development and analytical issues.

• Ability to identify, communicate and resolve complex issues.

• Ability to identify trends & changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.

• Strong oral and written skills

• Prior management skills preferred

#li-hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.