Global Regulatory Sciences Lead
3 weeks ago
At Bristol-Myers Squibb, we're transforming the lives of patients and the careers of those who do it. This role offers the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Key Responsibilities
- Lead global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health, and other devices enhancing our pharmaceutical products.
- Assess global regulatory landscapes, develop filing strategies, and ensure consistent positions in responses to global Health Authority queries.
- Collaborate with global teams to develop global submission plans and HA interaction plans, ensuring global development plans meet global regulatory requirements.
- Communicate regulatory strategy, issues, and risks to governing bodies, and drive quality decision-making and issue resolution.
Requirements
- Bachelor's degree required; advanced scientific degree preferred, with 5 years' experience, including 4+ years in US Medical Device Regulatory Affairs.
- Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives, and with clinical trial assays.
- Experience in global regulatory affairs, project management, and communication of scientific content.
- Ability to apply project management techniques, manage meetings, and drive quality decision-making.
- Understanding of general global regulatory requirements for drugs in development and R&D processes.
About the Role
As a Global Regulatory Sciences Lead at Bristol-Myers Squibb, you'll play a critical role in shaping our global regulatory strategy, ensuring compliance, and driving the development of innovative pharmaceutical products.
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