Senior Regulatory Submissions Specialist - eCTD & FDA
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate with cross-functional teams to align on FDA/ICH requirements and SOPs. The role offers a competitive package with flexible work options and comprehensive health benefits. #J-18808-Ljbffr Breckenridge Pharmaceutical
- Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance. You will also manage document workflows and corporate records...Suggested
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