Senior Manager, Regulatory Portfolio Manager

Senior Manager, Regulatory Portfolio Manager page is loaded Senior Manager, Regulatory Portfolio Manager Apply locations Uxbridge - GB time type Full time posted on Posted 2 Days Ago job requisition id R1582253

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 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: careers.bms.com/working-with-us

BMS Uxbridge is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Position Summary

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

This is a fully remote role.

Key Responsibilities

• Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Team (GRT) to deliver and execute the optimal regulatory strategy for assigned asset(s):
  • Co-lead GRT 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

Qualifications & Experience

• Degree or equivalent in healthcare related field
• 2+ 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
• 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

#LI-Remote

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.

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 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
BMS has a diverse 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.

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 careers.bms.com/ eeo -accessibility 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 is Disability Confident – Committed

A UK Government scheme

W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.