Associate Director, Oncology, Global Regulatory & Safety Sciences Lead (R1543340-en-us)
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.
Bachelors in scientific discipline; A minimum of 10 years pharmaceutical industry experience in in clinical regulatory affairs, inclusive of at least 7 years of 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.
- 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 of 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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.