Strategic Regulatory Affairs Director
6 days ago
About the Role
This role will lead the development of regulatory strategies to support the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
Responsibilities
- Lead global regulatory strategy development and implementation.
- Collaborate with cross-functional teams to develop global filing strategies.
- Develop and maintain relationships with global health authorities.
- Provide input into the development of protocol synopses and protocols.
- Contribute to the development of target labeling.
- Ensure global development plans meet global regulatory requirements.
- Develop and implement global submission plans and HA interaction plans.
- Contribute to cross-functional rapid response teams to respond to CTA queries.
Requirements
- Bachelor's degree required; advanced scientific degree preferred.
- 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience.
Key Competencies
- Leadership and team management skills.
- Regulatory strategy development and implementation.
- Experience with clinical trials and regulatory affairs.
- Communication and negotiation skills.
- Project management and organizational skills.
About Bristol Myers Squibb
Bristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through innovative medicines.
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