Regulatory Affairs Director for Precision Medicine and Digital Health Initiatives
22 hours ago
Bristol-Myers Squibb, a leader in precision medicine and digital health, seeks an experienced Regulatory Affairs Director to join our team. This is a challenging role that requires expertise in global regulatory strategy, leadership skills, and a passion for transforming the lives of patients.
About the Role
This position offers a unique opportunity to lead global regulatory strategy initiatives, develop filing strategies, and collaborate with cross-functional teams to drive submission plans and HA interactions.
Key Responsibilities
- Develop and execute global regulatory strategies to support biomarker, companion diagnostic test, and digital health device development.
- Leverage expertise in regulatory landscapes, risk assessments, and filing strategies to ensure compliance and efficient submissions.
- Co-lead marketing application submission teams for indications at regulatory filing stages, developing content strategies for global dossiers.
- Ensure consistent positions are presented in responses to global Health Authority queries.
- Promote a culture of collaboration and teamwork across regional regulatory strategy liaison input.
Requirements
- A bachelor's degree is required; advanced scientific degrees (Masters, PhD, PharmD, BSN) are preferred, with 5 years of industry experience, including 4+ years of US Medical Device Regulatory Affairs experience.
- Proven experience in developing regulatory strategies aligned with clinical plans and marketing objectives.
- Experience communicating between Diagnostic sponsor and Drug sponsor in clinical trial assays.
- Global Regulatory sub-team or project working group experience is highly desirable.
- Demonstrated ability to apply project management techniques within teams, manage meetings, and facilitate issue resolution.
- Strong analytical and problem-solving skills, with the ability to break down complex content into logical components.
- A salary range of $180,000 - $220,000 per annum reflects the company's commitment to attracting top talent and offering competitive compensation.
Why Choose Bristol-Myers Squibb?
Join a dynamic team dedicated to transforming the lives of patients through innovative research and development. As a Regulatory Affairs Director, you will have opportunities to grow professionally, work on high-profile projects, and contribute to the success of our company.
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