Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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: .

The role is to provide coordination and operational support to cross-functional regulatory teams and Country Regulatory to ensure regulatory portfolio deliverables are delivered to plan and in compliance with global processes and appropriate local regulatory requirements.

Position Responsibilities

Responsibilities include but not limited to:

Global Regulatory Support

• SharePoint Maintenance Activities;
• Trigger annual review of Regulatory Strategy Plan;
• Maintain HA engagement plan
• Support GRT member transition by setting up transition form

Execution of Regulatory Strategy

• 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

• Monitors key Health Authority Websites for pertinent information
• Compiles Regulatory precedents as requested

Global Regulatory Submissions Support

• Support planning and managing timely deliverable of critical regulatory deliverables (registration samples) and various Module 1 documents for ex-US,ex-EU countries
• Request certificates from respective Health Authority (FDA, EMA, Swiss Medic) and manage notification process

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

• Product Divestiture: Upload relevant documents into the Virtual Data Room (VDR) for potential buyers
• Product Deletions: Gather information from the Country Regulatory Managers for Product Deletions Strategy
• Interacts with Global Product Development & Supply (Last batch expiry) to ensure timely reporting to the respective Health Authority(ies)
• Maintain database for Product Deletion Requirements

HA queries / Shortage Notifications

• Schedule RRT meetings and communicate timelines
• Set up response templates to ensure submission readiness
• Submission of responses for publishing

Analytics / Compliance Activities

• Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones
• Review Verity and Infinity reports for Compliance related trends, eg HA commitments, Development commitments, open CAPAs, CAPAs coming due

Degree Requirements

• Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field

Experience Requirements

Qualifications/Requirements:

• \xe2\x89\xa5 2years in pharmaceutical industry and regulatory experience

Key Competency Requirements

• Solid understanding of at least one major Health Authority (FDA, EMA, MHRA \xe2\x80\xa6..) regulations and Regulatory standards
• Act as a role model & set a good example
• Identify, communicate and propose resolutions to routine/complex issues. Articulate the implication of issue to project team on risk/benefit strategic component.Establish strong working relationsships
• Good communication and organizational skills and a meticulous eye for details
• Facilitate negotiation with HAs & key partners on routine matters w/ supervisory consultation.
• Ability to make decisions in their sphere of influence
• Independently work on multiple projects & assignments.
• Ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline.
• Must possess an excellent command of language (English)
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed

• Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 . Visit 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.

Bristol-Myers Squibb