Senior Manager, Global Regulatory Strategy & Policy

Location
Summit East, NJ, United States
Posted
Sep 21, 2020
Ref
R1529687
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

POSITION

Senior Manager, Global Regulatory Strategy & Policy

SUPERVISOR

Senior or Executive Director, Global Regulatory Strategy & Policy

DEPARTMENT

Global Regulatory Strategy & Policy

Location

Seattle, Washington or Summit, New Jersey

PREREQUISITES

Bachelors in scientific discipline; 4-8 years pharmaceutical industry experience; Advanced degree in scientific discipline preferred.

Responsibilities will include, but are not limited to, the following:

  • Work with Global Regulatory Strategy Leader and/or US Regulatory Strategy Leaders and product Regulatory and Submission Teams to implement plans for cell therapy products for identified projects in development;
  • Lead and/or manage the preparation of submissions, which may include INDs, NDAs, Briefing Documents, Orphan Drug Applications, etc;
  • Work with cross-functional groups to define and manage contributions to submissions;
  • Participate in or lead the regional Regulatory Sub-team for assigned product(s)/project(s);
  • Effectively communicate Regulatory product/project objectives and progress to functional management and Regulatory Sub-team;
  • Participate in and/or lead regulatory interactions with FDA, as assigned;
  • Participate as Regulatory representative on various cross-functional teams;
  • Maintains and reinforces compliance with Company SOPs and Work practices;
  • Provide Regulatory research and intelligence support for teams, as assigned;
  • Maintain knowledge on the US Regulatory environment, regulations and guidances;
  • Become knowledgeable with America's Region (includes Canada and Latin America) and European Regulatory laws/guidances, respective to the program and planned regulatory submissions.

Skills/Knowledge Required:

  • Bachelors degree in scientific discipline; Advanced scientific degree preferred;
  • Experience in multiple phases of drug development; Experience in Cell Therapy Drug Development a plus;
  • 4-8 years pharmaceutical industry experience;
  • Good Understanding of the drug development process;
  • Strong experience with US Regulatory submissions and dossiers (eg, INDs; NDAs);
  • Inter-dependent partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment;
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously;
  • Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail;
  • Domestic and occasional International travel may be necessary.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.