Senior Regulatory Affairs Associate - Complex Generics
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical, Inc. in the United States, seeks a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes), support lifecycle management, and assist the Director of Regulatory Affairs. Focus on complex generics and drug-device combinations. You will author eCTD sections, prepare meeting packages under GDUFA III, coordinate with internal teams and external partners, and contribute to development from early formulation to final filing, #J-18808-Ljbffr Breckenridge Pharmaceutical
Vacancy posted 2 days ago
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