Regulatory Affairs Manager | FDA Submissions & eCTD
6AM City, LLC
6AM City, LLC in New Jersey seeks an experienced Regulatory Affairs professional to prepare and review multiple regulatory submissions (ANDAs and NDAs) and respond to FDA queries. You will devise strategies, review meeting packages, and provide cross-functional regulatory guidance for complex drug products while staying up-to-date with FDA regulations. Role requires a bachelor’s degree and 8+ years in regulatory strategy and filing, plus hands-on experience with eCTD build software. #J-18808-Ljbffr 6AM City, LLC
Vacancy posted 2 days ago
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