Regulatory Affairs Manager

Regulatory Affairs Manager (EU) | Leading Pharma We’re hiring a Regulatory Affairs Manager to support products in development and post-MAA, contributing to EU regional clinical regulatory strategy and supporting EU Regulatory Leads across global development and lifecycle activities within a leading pharmaceutical organisation. What you’ll do Lead and support planning, coordination, and preparation of EU regulatory submissions Contribute to EU clinical regulatory strategy and risk assessment/mitigation Provide regulatory guidance across R&D and product lifecycle activities Support and participate in EU Health Authority interactions and meeting preparation Help ensure post-approval compliance and inspection readiness What we’re looking for 5+ years’ pharma/biotech experience, including Regulatory Affairs experience EU regulatory submission experience (clinical and/or lifecycle) Strong understanding of EU regulations, guidelines, and submission processes Excellent communication, organisation, and stakeholder management skills Life/Health Sciences degree (preferred) About Planet Pharma: Planet 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. www.planet-pharma.com Please click ‘apply’ or contact Finlay Keyworth (Recruiter II) at Planet Pharma for more information: E: fkeyworth@planet-pharma.co.uk