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Freelance Regulatory Affairs Consultant

4 settimane fa

Rome, Italia Planet Pharma A tempo pieno
Job SummaryProvide 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 applicationsEnsure compliance with national regulations for marketing authorization applications (MAAs) and variationsReview and approve translations for artworks and product informationAssess promotional and non-promotional materials for regulatory compliance and obtain necessary approvalsAct as a regulatory expert, collaborating with clinical and technical teams throughout product developmentProvide guidance and troubleshooting on regulatory matters, ensuring adherence to standards and company policies

Qualifications & Skills:Expertise in Italian regulatory submissions, including variations, MAAs, and agency negotiations (AIFA)Strong communication, problem-solving, and teamwork skillsNative Italian speaker with fluency in EnglishProficiency in Microsoft Office and quality management processesDetail-oriented, analytical, and proactive

TO APPLYPlease click ‘apply’ or contact Harry Budge (Senior Recruiter) at Planet Pharma for more information:

E:

hbudge@planet-pharma.co.ukT:

: +44 2045 424 275LinkedIn: