Bristol Myers Squibb Company

Associate Director Regulatory Affairs

Location
Jersey City, NJ, United States
Posted
Sep 16, 2020
Ref
R1526294
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

Director, Regulatory Affairs

SUPERVISOR

Senior or Executive Director, Regulatory Affairs

DEPARTMENT

Global Regulatory Affairs
PREREQUISITES

Bachelors in scientific discipline; A minimum of 10 years pharmaceutical industry experience in in clinical regulatory affairs, inclusive of at least 7 years experience in a senior regulatory leadership role formulating strategy and driving decision-making. Advanced degree preferred.

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

Serve as Global Regulatory Strategy Leader for late stage marketed product with multiple indications. For each indication, will:
  • Develop and create strategy for long-term planning at a cross functional level for product, consistent with the corporate and project objectives.
  • Represent regulatory in senior management discussions and present issues accordingly.
  • Interface with international affiliates on regional regulatory strategy and implementation plans.
  • Provides strategic direction to Regional Regulatory Strategy Lead in preparing teams for project related interactions with Regulatory Agency(ies).
  • May engage with Regulatory Agency(ies) on project related interactions.

Provide innovative solutions to challenging opportunities. Responsible for the development of global regulatory strategies, in collaboration with the Global Regulatory Team and Strategic Regulatory Intelligence and Policy, which are consistent with the global Project Team goals and objectives. Accountable for ensuring the appropriate implementation of the global regulatory strategy. Identify issues proactively (i.e. regulatory or competitive) that will impact programs and provide strategies to address them. Communicate these issues to the Global regulatory strategy leader, global regulatory sub-team and to functional management. Provides insight and recommendations on health authority guidance in collaboration with the strategic liaison, policy, and regulatory intelligence group. Conduct Business Development diligence efforts, if assigned. Be a strategic partner and team player in the various decision-making committees within the company.

Skills/Knowledge Required:

  • Completed Bachelor's degree in a scientific discipline required.
  • Must have at least 10 years pharmaceutical industry experience in clinical regulatory affairs, inclusive of at least 7 years experience in a senior regulatory leadership role formulating strategy and driving decision-making.
  • Must be able to travel overnight for business 15% or more, depending on project needs.


FOR FURTHER INFORMATION, PLEASE CONTACT HUMAN RESOURCES

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.