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.
Director, Regulatory Affairs
Senior or Executive Director, Regulatory Affairs
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
Serve as Global Regulatory Strategy Leader for late stage
marketed product with multiple indications. For each indication,
Develop and create strategy for long-term planning at a cross
functional level for product, consistent with the corporate and
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
May engage with Regulatory Agency(ies) on project related
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
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.
W e’re creatinginnovative 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