Regulatory Specialist, Portfolio Acceleration and Analytics

Regulatory Specialist, Portfolio Acceleration and Analytics

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

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:

• 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

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

• Tracks deletion notifcations 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

Analytics / Compliance Activities

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

 

Technology & Analytics Adoption –

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

 

Degree Requirements

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

 

Experience Requirements

Qualifications/Requirements: 

• 0- 2 years in pharmaceutical industry

Key Competency Requirements

• Basic understanding of FDA, EMA or other  Health Authorities and Reporting regulations and standards;

• Act as a role model & set a good example

• Identify and communicate routine issues.

• Establish strong working relationships

• Good communication and organizational skills and a meticulous eye for details

• Interact w/ key partners or HA on routine matters w/ supervisory consultation.

• Ability to make  decisions in their sphere of influence

• dependently work on multiple 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

• Good understanding of pharmaceutical or medical terminology

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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.

Candidate Rights

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

For roles based in Los Angeles County only:  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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607282 : Regulatory Specialist, Portfolio Acceleration and Analytics

Experience Level

Mid Level