Bristol Myers Squibb
biotechnology • innovation • great place to work • pharmaceuticals • research and development
Director - Regulatory Affairs, CMC
4 days ago
🇺🇸 United States – Remote
💵 $204.4k - $276.6k / year
⏰ Full Time
🔴 Lead
🚔 Compliance
🦅 H1B Visa Sponsor
Bristol Myers Squibb
biotechnology • innovation • great place to work • pharmaceuticals • research and development
Description
• Oversee/manage CMC regulatory functions • Guide global regulatory strategy for radiopharmaceuticals • Prepare regulatory submission documents • Manage CMC documentation for development and validation • Research US and international regulations • Participate in Global Regulatory Team for submission plans
Requirements
• Bachelor’s degree or higher • 10 or more years of hands-on regulatory experience • Authoring experience with IND, IMPD, NDA, MAA, and/or DMF CMC sections is required • Understanding of phase-appropriate data requirements for regulatory filings is desired • Experience with complex aseptic formulations is essential • Strong leadership and teamwork in a cross-functional industry environment • Excellent written and verbal communication skills
Benefits
• Wide variety of competitive benefits • Resources to pursue personal goals
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