Senior Regulatory Affairs Lead - Biologics FDA Submissions
BioSpace
ADMA Biologics, a biopharmaceutical company focused on immunodeficient patients, is seeking a Senior Manager, Regulatory Affairs for onsite work in Boca Raton, FL. The role leads regulatory submissions, provides strategic guidance, and partners with FDA and internal teams to ensure compliance for investigational and marketed products. Ideal candidate has 10+ years in regulatory affairs, strong Biologics/BLA experience, and hands-on expertise with eCTD and submission systems. #J-18808-Ljbffr BioSpace
Vacancy posted 2 days ago
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$160k
...Description Job Description Senior Manager, Regulatory Affairs The Senior Manager,... ...interpreting regulatory documents for submission to the U.S. Food and Drug Administration (FDA). Serves as a liaison with... ...Drug Applications (INDs), Biologic License Applications (BLAs),...SeniorContract workOpenwork
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