Freelance Regulatory Affairs Consultant Lazio

Freelance Regulatory Affairs Consultant
Roma
Lazio, Lazio

Job Summary Provide regulatory and technical support for assigned products, including submissions, documentation, and project-related regulatory activities. Key Responsibilities: Stay updated on local regulatory requirements, communicating changes to stakeholders.

Handle inquiries on compassionate use, early access programs, labeling exemptions, and clinical trial applications Ensure compliance with national regulations for marketing authorization applications (MAAs) and variations Review and approve translations for artworks and product information Assess promotional and non-promotional materials for regulatory compliance and obtain necessary approvals Act as a regulatory expert, collaborating with clinical and technical teams throughout product development Provide guidance and troubleshooting on regulatory matters, ensuring adherence to standards and company policiesQualifications Skills: Expertise in Italian regulatory submissions, including variations, MAAs, and agency negotiations (AIFA) Strong communication, problem-solving, and teamwork skills Native Italian speaker with fluency in English Proficiency in Microsoft Office and quality management processes Detail-oriented, analytical, and proactiveTO APPLY Please click 'apply' or contact Harry Budge (Senior Recruiter) at Planet Pharma for more information:E:****** T:: +44 2045 424 275 LinkedIn: