Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000
Senior Manager, CMC Regulatory Affairs
October 10
Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000
Description
• Responsible for developing and implementing global regulatory CMC strategies. • Manage regulatory CMC aspects of compounds through all phases of development. • Provide CMC regulatory support and guidance for assigned projects. • Manage interactions with FDA and global regulatory authorities. • Develop effective regulatory CMC strategies for global submissions. • Manage/prepare CMC document packages for regulatory submissions.
Requirements
• 7+ years of experience with a Bachelor of Science degree, in a related scientific discipline, or 5+ years of experience with a higher-level degree. • Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and commercial product lifecycle including Phase 1-3, and marketed products).
Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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