Job Details

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.

Position Summary

Partners closely with the Regulatory Portfolio Manager.  Liaises with Global Regulatory Leader and other members of the Regulatory Strategy Team to deliver the asset’s book of work within the overall drug development process. Additionally, collaborate within Regulatory Innovation & Enterprise Delivery on above project initiatives

Key Responsibilities
Responsibilities include but not limited under the direction of the Regulatory Portfolio Manager (Senior Manager I) guidance:

Global Regulatory Support

• Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making, project availability dependent

Execution of Regulatory Strategy

• Develop and maintain asset global regulatory BoW
• Liaise cross-functionally to generate periodic internal milestone report
• Communicate status and timeline changes
• Tracking key regulatory milestones as defined by the GRT, health authority meetings, post-approval commitments, annual reports, etc.

Regulatory Intelligence

• Performs complex analyses, as directed
• Monitors key Health Authority Websites for pertinent information
• Compiles Regulatory precedents as requested
• Creating and supporting database for Global Submission Country requirements (CMC, IVDR,…)for new and Post Approval submissions

Global Regulatory Submissions Support

• Support submission team meetings ROW

Support of Divestitures / Product Deletions / Product Termination / Asset Integration

• Product Divestiture:
• Works with the Divestiture Reg Lead to document any gaps to be disclosed to the buyer
• Works with Divestiture Reg Lead on implementation of MAT transfers, provides status updates
• Coordinates review of Asset Purchase Agreement, Transitional Service Agreement
• Asset / Company Integration:
• Gathers information to support Sponsorship Change Strategy
• Support Integration Lead in meetings with cross-functional team

HA queries / Shortage Notifications

• Coordination of HA responses (work with respective GRL, RPM, CMC-L, International Lead, EU Lead)
• Schedule RRT meetings and communicate timelines
• Review HAQ in Verity to identify, whether similar query was previously received
• Follow-up with SME in response sections

Analytics / Compliance Activities

• Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones

Qualifications & Experience
College senior or Graduate/Profession student in life science, scientific or engineering discipline

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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