Senior Regulatory Affairs Consultant Venezia

Senior Regulatory Affairs Consultant
Venezia
Veneto, Venezia

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Planet PharmaClient Dedicated Talent Acquisition Partner at Planet PharmaSenior Regulatory ConsultantContract Duration: 1 year InitiallyCompany: Global Pharmaceutical CompanyJob SummaryProvide local regulatory and technical support for assigned products, including regulatory submissions, product development documentation, and the management of project-related regulatory activities. Key ResponsibilitiesMonitor and stay updated on local regulatory requirements, anticipating and communicating changes to relevant stakeholders. Support responses to inquiries from other departments (e. g. , medical, supply chain) regarding compassionate use, early access programs, labeling exemptions, clinical trial application (CTA) requirements, etc. Ensure compliance with national requirements related to marketing authorization applications (MAAs) and subsequent variations for centrally approved products. Review and approve translations for artworks and product information. Assess promotional and non-promotional materials for compliance with local regulations, submitting or obtaining approvals where necessary. Act as a regulatory expert in multidisciplinary teams, collaborating with clinical and technical professionals throughout product development. Provide guidance and troubleshooting support on regulatory matters, offering practical solutions to project-related challenges. Ensure adherence to local regulatory standards, policies, and company procedures. Qualifications & SkillsBS or PhD in a science-related field or equivalent experience in regulatory affairs, medical writing, or a related domain. At least 6 years of experience in the pharmaceutical or biotech industry within regulatory affairs. Proven expertise in preparing Italian regulatory submissions, including variations, responses to agency queries, and MAAs. Experience managing negotiations with AIFA. Strong communication and interpersonal skills, with excellent written and verbal proficiency. Native Italian speaker with fluency in English (spoken, written, and reading). Strong problem-solving abilities and experience working in cross-functional teams. Proficiency in Microsoft Office applications. Attention to detail, analytical mindset, and proactive approach to tasks. Good understanding of quality management processes. Seniority levelMid-Senior levelEmployment typeContractJob functionConsulting, Health Care Provider, and OtherIndustriesPharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr