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Position Summary:

The Associate Director, GRS PMDH leads global regulatory strategies to support the development and approval of biomarkers, companion diagnostic tests, digital health solutions, and other devices associated with pharmaceutical products across therapeutic areas. This role involves assessing regulatory landscapes, managing regulatory risks, and developing global filing strategies. The Associate Director co-leads marketing application submission teams, ensures consistent responses to global Health Authority (HA) queries, and integrates regional regulatory strategies into global development plans. Additionally, the role includes providing input into protocol development, responding to Clinical Trial Application (CTA) queries, and contributing to the development of target labeling. The position requires a strong background in regulatory affairs, team leadership, and project management within the medical device and pharmaceutical industries.
Duties/Responsibilities

• Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
• Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
• Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
• Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
• Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans.
• Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
• Contribute in the developing of target labeling.
• Reporting Relationship Executive Director, Regulatory Affairs, Precision Medicine and Digital Health

Qualifications

• Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with at least 7 years of US or EU Medical Device Regulatory Affairs experience

Specific Knowledge, Skills, Abilities:

• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development.
• Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
• Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.
• Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry.
• Experience with communication of regulatory strategy, issues, and risks in written and verbal format within teams, across functions and to governing bodies.
• Ability to apply project management techniques within teams and effectively manage meetings.
• Demonstrated ability to breakdown complex, scientific content into logical components.
• Ability to coordinate global activities, facilitate issue resolution and conflict management.
• Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
• Demonstrated ability to negotiate with and influence others.
• Understanding of strategic and tactical role for the drug development process
• Understanding of general global regulatory requirements for drugs in development.
• Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.

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.

Compensation Overview:

• Warsaw
• PL: zł361,740 - zł438,337

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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 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:

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.

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 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/

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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1596272 : Associate Director, Precision Medicine Digital Health