Associate Director, Regulatory Affairs (R1557808-en-us-3)
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.
The Associate Director, Regulatory Affairs will develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.
Lead global and/or regional regulatory team on assigned projects. Develop and execute US regulatory strategy and contingencies for assigned projects. Serve as the primary interface for FDA on assigned projects.
Lead the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for assigned projects.
Prepare company team for FDA and other health agency meetings, as required. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
5-9 years of pharmaceutical industry experience, including 3-5 years in regulatory affairs. Global experience is desired.
Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune diseases is a plus.
Thorough knowledge of the drug development process, IND and NDA process. Demonstrated experience in preparing FDA submissions.
Inter-dependant partnering skills, team-oriented and 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 critical 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.
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.
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