Senior Regulatory Consultant

3 settimane fa

Giuliano di Roma, Italia Planet Pharma A tempo pieno
Title:

UK&I Corporate Affairs AssociateCompany:

Global Leading BiotechnologyLocation:

Hybrid - Uxbridge/Cambridge

Planet Pharma is partnered with a global leading CRO company who are currently seeking a Senior Regulatory Consultant on a predominantly remote basis.

Main Responsibilities:Provide local regulatory and technical support for assigned products, including product development documentation, regulatory submissions, and project management.Ensure correct application of national requirements for Marketing Authorization Applications (MAAs) and variations for Centrally Approved products.Review and approve translations for artworks and product information.Evaluate promotional and non-promotional materials for compliance with local regulations.Act as a local regulatory expert in multidisciplinary project teams, collaborating with clinical and technical experts throughout the product lifecycle.Provide regulatory expertise and support team members in resolving day-to-day regulatory challenges by offering practical solutions.

Main Requirements:Previous string experience in regulatory affairs within pharma or biotech or CRO.Experience with Italian regulatory submissions - variations, agencies queries handling, MAAs.Experience managing negotiations with AIFA.

Interested? Apply now for immediate consideration or contact Maria Tsalpatourou at

ABOUT PLANET PHARMAPlanet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.We are an equal opportunities Recruitment Business and Agency.We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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