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Sr. Regulatory Affairs Analyst
1 semana atrás
Challenging. Meaningful. Life-changing. Those words aren't commonly associated with a job. But at Bristol Myers Squibb, things are far from ordinary. Here, every department experiences unique and interesting work daily. From optimizing production lines to groundbreaking advancements in cell therapy, the work done here positively impacts patients' lives and boosts the careers of those involved. You'll have the opportunity to grow in ways you never imagined, surrounded by diverse and high-achieving teams. Take your career to new heights.
Position OverviewThe Regulatory Affairs department plays a strategic role in the company's growth. Managing regulatory processes with ANVISA allows the company to expand and update its product portfolio. The regulatory landscape is always evolving, demanding readiness to anticipate, analyze, plan, and execute changes efficiently and effectively. Moreover, the Regulatory Affairs team ensures compliance with health regulations to sustain operations, avoid penalties, and safeguard the company's reputation. The Regulatory Affairs Senior Analyst must thrive in this dynamic environment, delivering expected outcomes autonomously and collaboratively in a timely and high-quality manner.
The role adheres fully to BMS laws, regulations, policies, and procedures, including business standards, as well as BMS Conduct and Ethics.
Travel RequiredYes
Direct ReportsNo
Objectives/Responsibilities Include, but Are Not Limited To:- SPEED TO PATIENT
Understands and complies with current and local regulations and internal policies, evaluating the impact of evolving changes, and planning and executing regulatory processes:
- Preparing major filings independently, such as BLA, NDA, LCM, and DDCM, aligned closely with pipeline submission plans and targeted timelines.*
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