Senior Manager I, RPM

The Regulatory Portfolio Manager collaborates with Global Regulatory Leads and Sub-Teams to develop and execute optimal regulatory strategies for assigned assets. Key responsibilities include co-leading sub-team meetings, managing the global regulatory book of work and submission plans, tracking milestones, and providing operational support for strategic documents. The role also involves coordinating rapid responses to health authority queries and supporting US regulatory activities.

Must Have

• Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s).
• 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.
• Develop and maintain the asset’s global regulatory book of work and Global Submission Plan.
• Track key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
• Liaise cross-functionally to generate periodic internal milestone reports.
• Maintain global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities.
• Communicate status and timeline changes.
• Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan.
• Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
• Review prior health authority queries to guide response development.
• Represent the Global Regulatory Lead in team as needed.
• Partner with the US Regulatory Lead to co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents.
• Support and co-ordinate preparations for FDA meetings.
• Provide additional support e.g., precedent analysis.
• 3+ years of direct regulatory experience with developing knowledge of US and/or EU procedures.
• Ability to work independently and at pace in a global matrix environment and effectively prioritize multiple projects.
• Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan.
• Continuous improvement mindset.
• Strategic problem solver.
• Good communication and negotiation skills.
• Good interpersonal skills.
• Degree or equivalent in healthcare related field.

Perks & Benefits

• Benefits and Wellbeing: Global platform and benefits for physical, mental, financial and social wellbeing.
• Recognition: Global platform to reward your achievements.
• Time Off: Generous time off to rest and recharge.
• Health Benefits: Best-in-class benefits.
• 8 People & Business Resource Groups.
• 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.

Life at BMS

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. 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.

Job Summary

The Regulatory Portfolio Manager partners with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. The role reports directly to a Group Leader in Regulatory Portfolio Management.

Responsibilities:

• Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s):
• 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
• Develop and maintain the asset’s global regulatory book of work and Global Submission Plan including:
• Tracking key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
• Liaise cross-functionally to generate periodic internal milestone reports
• Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities
• Communicate status and timeline changes
• Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
• Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
• Review prior health authority queries to guide response development
• Represent the Global Regulatory Lead in team as needed
• Partner with the US Regulatory Lead to:
• Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
• Support and co-ordinate preparations for FDA meetings
• Provide additional support e.g., precedent analysis

Regulatory Portfolio Managers may also:

• Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellence
• Engages with customers to enhance RPM support
• Degree or equivalent in healthcare related field

Requirements:

• 3+ years of direct regulatory experience with developing knowledge of US and/or EU procedures
• Ability to work independently and at pace in a global matrix environment and effectively prioritize multiple projects
• Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan
• Continuous improvement mindset
• Strategic problem solver
• Good communication and negotiation skills
• Good interpersonal skills

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: zł230,270 - zł279,037

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.

R1597210 : Senior Manager I, RPM