REGULATORY AFFAIRS SPECIALIST

Overview Position: REGULATORY AFFAIRS SPECIALIST Location: Siena, Italy Department: Clinical Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is expanding its clinical activities in its Milan office. The Regulatory Affairs Specialist will report to the Regulatory Affairs Manager and will support the formulation and implementation of regulatory strategies for the development of Company Products in close collaboration with other Clinical Department functions. Responsibilities Lead and manage activities related to the submission and approval of products and product transfers to government regulatory agencies, including US and EU bodies. Develop content, timelines, and contingencies for submissions in collaboration with internal and external contributors. Ensure submissions are of high quality, meet regulatory requirements, and align with corporate goals and directives. Review draft registration files and submit new and amended registration dossiers to obtain and maintain registrations. Gather, evaluate, and organize information necessary for regulatory agencies and other third parties. Coordinate and participate in preparation of regulatory submissions (e.g., dossiers, variations, scientific advice submissions, INDs) for authorities worldwide for approved and developmental products. Provide regulatory feedback to project teams and senior management. Coordinate with competent authorities for respective projects/products and interact with internal departments. Register, update, and post results of Philogen studies in mandatory clinical trials and publication databases. Manage procedures related to Marketing Authorisation Applications for EMA and FDA. Update the Trial Master File and archive documentation with respect to Competent Authorities and Ethics Committees in collaboration with the CTA. Prepare and revise controlled documents including clinical forms, templates, and SOPs related to Regulatory Affairs. Train clinical staff in regulatory policies or procedures. Stay up-to-date with regulatory changes and assess their impact on department activities. Preferably experience with, or awareness of, key electronic submission tools. Requirements University degree in science (preferred). At least 5 years' experience in regulatory affairs. Experience in Regulatory Life Cycle Management and eCTD is an advantage, though not required. Thorough understanding of ICH GCP and worldwide regulatory requirements (particularly FDA and EMA). Excellent written and oral communication skills. Excellent level of English, both written and spoken. We offer A contract and salary proportional to the experience of the successful candidate. Location Job location: Milano/Siena - Italy How to apply / Legal notices Interested candidates are invited to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006. We welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. J-18808-Ljbffr

Location: Siena, Toscana, IT

Posted Date: 9/16/2025