Regulatory Associate

Position Summary To assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country(ies) and ensure compliance with local and international clinical trials regulations and guidelines. Responsibilities Keep an updated knowledge of the local clinical trial laws, regulations and guidelines to perform the assigned regulatory activities. Prepare Clinical Trial Application Forms (Country EudraCT form for EEA countries and/or National Application Form). Prepare submission dossiers (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorisations/approvals for the conduct of the clinical trial. Interact with CA/EC for study purposes and handle responses to CA/EC. Provide CA/EC related information as needed. Provide regular updates about CA and EC submissions to the Vice President Regulatory/Designee, the responsible person coordinating the submissions, the Clinical Project Manager and the responsible Lead. Participate in regulatory activities within the company and ensure CA/EC related activities are performed according to international and local/national applicable regulations, company SOPs and ICH-GCP principles. Attend Regulatory as required. Assist in training CRAs (if applicable) to ensure they have the necessary knowledge for preparation of the clinical documents required for regulatory submissions. Assume other regulatory responsibilities if required and upon the request of the Director, Regulatory / VP, Regulatory. Qualifications Medical/science background and/or relevant experience Prior clinical research and regulatory submissions experience Fluent in Italian and English Computer literacy Good communication and interpersonal skills Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. 2020 Precision Medicine Group, LLC J-18808-Ljbffr

Location: Milano, Lombardia, IT

Posted Date: 9/16/2025