Bristol Myers Squibb Regulatory Coordinator, Global Regulatory Strategy, Oncology in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
In conjunction with Regulatory Leads, coordinate creation and approval of global regulatory plans, and transmit to internal and external experts to execute the plan
Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
Manage, track, review regulatory deliverables from external partners in line with vendor manager
Maintain regulatory work schedules with vendors and vendor managers for assigned project using common data-points and milestones
Coordinate GRS support for HA interactions lead by regional / local liaisons
Support Regulatory Lead is the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc)
Provide support for tracking progress and resolving issues with CTA preparations and submissions and approvals
Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
Coordinate preparation of response to HA questions according to a rapid response process for assigned projects
Maintain tracking data in PMC and PMR database
Coordinate regulatory communications required for regulatory actions to regional and local regulatory
Writing, reviewing signing and submission of maintenance regulatory documents for all IND/CTAs - All within group with consultation of the USL, EUL or GRTL as needed
Annual Reporting Responsibilities for regulatory owned components
Support submission of US BLA/NDA submissions, as assigned.
This position is based in Lawrenceville, New Jersey
Working knowledge of regulatory procedures (US or other) or in a specific therapeutic area (2-3 years).
Demonstrates a high-level of self-motivation and professional commitment. (In)direct management experience of people or major projects.
Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills.
Excellent communication skills.
Comprehensive understanding of the pharmaceutical industry.
Comfortable working in a fast-paced environment where speed is paramount
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
Ability to recognize, articulate, and accept calculated risks to make informed decisions
Willingness and ability to effectively cooperate and partner with external vendors and BMS
Develop understanding of different TAs due to assignment to different projects.
Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
Increased exposure to global and multifunctional teams.
Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences.
We’re creating innovative 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.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.