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Associate Director, Global Regulatory Sciences, Precision Medicine
3 months ago
Challenging. Meaningful. Life-changing. That's how we describe working at Bristol Myers Squibb. We're not your average company. Every day, in every department, we're doing unique and impactful work. Whether it's optimizing a production line or making breakthroughs in cell therapy, our work directly impacts patients' lives and our employees' careers. You'll have the opportunity to grow and thrive in ways you never imagined. Join our high-achieving teams, rich in diversity, and take your career to new heights.
Bristol Myers Squibb values work-life balance and flexibility. We provide competitive benefits, services, and programs that support our employees in achieving their goals, both at work and in their personal lives.
Position Responsibilities:- Lead global regulatory strategy for the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of our pharmaceutical products.
- Understand regulatory landscape, assess risks, and develop global filing strategies.
- Lead marketing application submission teams, develop content strategy for global dossiers.
- Ensure consistency in responses to global Health Authority queries.
- Collaborate with regional regulatory strategy liaison to ensure global development plans meet requirements.
- Contribute to the development of protocol synopses, target labeling, and more.
- Bachelor's degree required; advanced scientific degree preferred with at least 5 years in the industry.
- Minimum 4+ years of US Medical Device Regulatory Affairs experience.
- Proven experience leading teams and representing regulatory functions on project teams.
- Ability to develop regulatory strategies in alignment with clinical and marketing plans.
- Experience in clinical trial assays and communicating between Diagnostic and Drug sponsors.
- Strong communication and project management skills, ability to drive quality decision-making.
- Understanding of global regulatory requirements, drug development process, and more.
If you find a role that interests you, even if it doesn't perfectly match your resume, we encourage you to apply. You could be on the brink of a career-transforming opportunity.
Join us at Bristol Myers Squibb, where every employee contributes to transforming patients' lives through science. Our inclusive culture empowers individuals to apply their unique talents and perspectives, fostering diversity in clinical trials and upholding our shared values of passion, innovation, and integrity.
About On-site Protocol: Our company structure includes various types of roles, each requiring different levels of onsite presence. We value workplace accommodation and support, ensuring that all employees can excel in their roles.
Bristol Myers Squibb values employee well-being and strongly encourages Covid-19 vaccination and boosters. We consider qualified applicants with arrest and conviction records, and prioritize data privacy in job applications.
We are committed to creating innovative medicines and fostering a diverse team. Every role is essential in making a difference.
