Regulatory Specialist, Portfolio Acceleration and Analytics

Job Description

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.

Position Responsibilities

Responsibilities include but not limited to:

• SharePoint Maintenance Activities; Support GRT member transition by setting up transition form (operational)
• Execution of Regulatory Strategy: Liaise cross-functionally to generate periodic internal milestone report
• Regulatory Intelligence: Performs simple analyses as directed
• 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
• Shipping of documents, as required
• Admin- scanning, copying, shipping label
• 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
• Tracks deletion notifications to country Reg HA
• Asset Integration: Upload incoming documents to the BMS systems, ensure correct update of meta data; Remediation of documents, as directed
• HA queries / Shortage Notifications: Schedule RRT meetings and communicate timelines
• Set up response templates to ensure submission readiness
• Submission of responses for publishing
• Technology Analytics Adoption: Embrace and apply analytics and technologies to the BoW activities and process

Technology Analytics Adoption

Embrace and apply analytics and technologies to the BoW activities and process.

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.

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 a supportive culture, promoting global participation 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 an 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.

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 accommodations/adjustments prior to accepting a job offer.

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

We will never request payments, financial information, or social security numbers during our application or recruitment process.