Bristol-Myers Squibb Company

Regulatory Coordinator, Global Regulatory Strategy, Oncology

Location
Princeton, NJ, US
Posted
Apr 12, 2018
Ref
R1505458
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities
  • 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.


Qualifications
  • Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
  • A minimum of 5 years of scientific experience.
  • Demonstrates a high-level of self-motivation and professional commitment. (In)direct management experience of people or major projects.
  • 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
  • Increased exposure to global and multifunctional teams.
  • Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences.