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Regulatory Sciences Director
2 months ago
Transforming Lives through Regulatory Excellence
Bristol Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a talented Regulatory Sciences Director to join our team. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulations.
Key Responsibilities:
- Develop and implement global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health devices.
- Lead cross-functional teams to develop global filing strategies and ensure consistent positions are presented in responses to global Health Authority queries.
- Collaborate with the Global Regulatory sub-team to develop global submission plans and Health Authority interaction plans.
- Provide input into the development of protocol synopses and protocols, and contribute to cross-functional rapid response teams to respond to Clinical Trial Application queries.
- Contribute to the development of target labeling and ensure global development plans meet global regulatory requirements.
Requirements:
- Bachelor's degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry and at least 4+ years of US Medical Device Regulatory Affairs experience.
- Experience in successfully leading teams, developing regulatory strategies, and communicating regulatory strategy, issues, and risks in written and verbal format to governing bodies.
- Ability to apply project management techniques, drive quality decision-making, and negotiate with and influence others.
About Us:
Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming lives through innovative medicines and therapies. We're a company that values diversity, inclusion, and collaboration, and we're seeking talented individuals who share our passion for making a difference in the lives of patients.
