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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: (url removed)/working-with-us.
Position Responsibilities
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.
Degree/Experience Requirements
Ph.D., M.D., PharmD., MS or commensurate experience. Significant experience in regulatory affairs (e.g. 3-5 years)
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-dependent 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.
The starting compensation for this job is a range from $141,000 - $210,000 plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit: (url removed)
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@(url removed). Visit (url removed)/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
