Bristol Myers Squibb
biotechnology • innovation • great place to work • pharmaceuticals • research and development
10,000+
Senior Manager, Regulatory Affairs
2 days ago
Bristol Myers Squibb
biotechnology • innovation • great place to work • pharmaceuticals • research and development
10,000+
Description
• Oversee/manage clinical and nonclinical regulatory functions within RayzeBio • Serves as Global Regulatory Lead (GRL) Regulatory strategy • Lead Label Working Group (LWG) to execute strategy in alignment with company goals • Generation of regulatory documents for regulatory interactions • Maintain expert knowledge of relevant regulatory landscape • Lead preparation and submission of regulatory filings
Requirements
• Bachelor’s degree or higher • 5 or more years of hands-on regulatory experience • Experience of clinical regulatory strategy in oncology would be a distinct advantage • Demonstrable record of strong leadership and teamwork in a cross-functional industry environment • Demonstrated knowledge of US Labeling Lead and Company Core Data Sheet (CCDS Lead) • Experience working as a Global Regulatory Lead (GRL)
Benefits
• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives
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