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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: (url removed)/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 centre 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
#HYDDD
#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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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@(url removed). Visit (url removed)/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
