Senior Regulatory Consultant
2 settimane fa
Location: 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 strong 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
Seniority levelAssociate Employment typeFull-time Job functionScience Industries: Pharmaceutical Manufacturing and Biotechnology Research We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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