Associate Director, Global Regulatory Strategy
vor 3 Wochen
**Working with Us**
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.
**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 mínimal 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.
- 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.
**Uniquely Interesting Work, Life-changing Careers**
**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 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.
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