Senior Manager of Regulatory Affairs

A company is looking for a Senior Manager, Regulatory Affairs. Key Responsibilities Manage regional regulatory activities as part of the Global Regulatory Team Lead the preparation and coordination of US regulatory submissions and responses to health authority information requests Review nonclinical, clinical, and CMC documentation, contributing to content as needed Required Qualifications B.S. degree, preferably in a scientific discipline 4 years of experience in the biopharmaceutical or pharmaceutical industry, with a focus on regulatory affairs Experience with electronic regulatory submissions and regulatory templates Solid understanding of FDA and ICH regulations related to clinical research and product development Familiarity with EU Clinical Trial Regulation and ROW country regulatory requirements is a plus

Apr 23, 2025 - 19:59

A company is looking for a Senior Manager, Regulatory Affairs. Key Responsibilities Manage regional regulatory activities as part of the Global Regulatory Team Lead the preparation and coordination of US regulatory submissions and responses to health authority information requests Review nonclinical, clinical, and CMC documentation, contributing to content as needed Required Qualifications B.S. degree, preferably in a scientific discipline 4 years of experience in the biopharmaceutical or pharmaceutical industry, with a focus on regulatory affairs Experience with electronic regulatory submissions and regulatory templates Solid understanding of FDA and ICH regulations related to clinical research and product development Familiarity with EU Clinical Trial Regulation and ROW country regulatory requirements is a plus