Senior Regulatory Affairs Specialist
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
- The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements. Essential Functions Serve as a Regulatory Affairs subject matter...SeniorWork at office
$115k - $135k
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AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines...For contractorsLocal area$121.07k - $146.7k
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