Associate Director Global Regulatory Sciences

vor 1 Woche

Boudry, Schweiz Bristol Myers Squibb Vollzeit

**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.
- Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research
- Independently manage and prioritize multiple complex projects
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Identify, communicate and propose resolutions to routine/complex issues
- Interpret global regulations and guidance. Identify regulatory opportunity and risks.
- Anticipate and communicate possible regulatory paradigm shifts
- Participate in product fact finding meetings
- Review and provide regulatory assessments on change controls
- Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
- Mange relationships with diverse teams
- Utilize electronic systems for dossier creation and tracking

**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.

**COVID-19 Information**

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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