Senior Manager, Regulatory Portfolio Manager

2 weeks ago

Uxbridge Greater London, United Kingdom Bristol-Myers Squibb Full time
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 R Working with Us

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.

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.

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.
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; 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., Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset's priorities
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
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

Regulatory Portfolio Managers may also:
Degree or equivalent in healthcare related field
~2+ years of direct regulatory experience with developing knowledge of US and/or EU procedures
~ able to lead through influence and building alignment with stakeholders to deliver projects to plan
~ LI-Remote

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.

This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. 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 .

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

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