Senior Regulatory Strategist

A company is looking for a Senior Regulatory Strategist to provide expert consultation on regulatory requirements for clinical trials and submissions. Key Responsibilities Provide expert consultation and advice on regulatory agency interactions and communications Support the preparation of regulatory submissions and manage project teams Build and maintain strong relationships with clients and regulatory agencies Required Qualifications Bachelor's degree in a related field required; advanced scientific degree preferred 15 years of relevant experience, with at least 10 years in regulatory affairs within clinical research or pharmaceutical settings Thorough knowledge of ICH guidelines and regulatory rules, along with medical terminology and clinical trials Experience as an authorized regulatory representative with a proven track record in global submissions In-depth knowledge of the CRO industry and its relationship with pharmaceutical/biotech companies

Apr 3, 2025 - 21:17

A company is looking for a Senior Regulatory Strategist to provide expert consultation on regulatory requirements for clinical trials and submissions. Key Responsibilities Provide expert consultation and advice on regulatory agency interactions and communications Support the preparation of regulatory submissions and manage project teams Build and maintain strong relationships with clients and regulatory agencies Required Qualifications Bachelor's degree in a related field required; advanced scientific degree preferred 15 years of relevant experience, with at least 10 years in regulatory affairs within clinical research or pharmaceutical settings Thorough knowledge of ICH guidelines and regulatory rules, along with medical terminology and clinical trials Experience as an authorized regulatory representative with a proven track record in global submissions In-depth knowledge of the CRO industry and its relationship with pharmaceutical/biotech companies