Walker Cole International is searching for a Regulatory Affairs Manager to join a global pharmaceutical company. As the Regulatory Affairs Manager you will be responsible for UK, EU, and global regulatory activities including lifecycle management, submissions to UK, EU, and Global regulatory bodies, preparing CMC modules for new MAAs, and acting as a point of contact for all regulatory activities.

The main responsibilities of the Regulatory Affairs Manager will include:

Management of UK, EU, and Global regulatory submissionsReview CMC dossiers and components (e.g MAAs, deficiencies, variations, IMPD/IND CMC components)Proactively contributing to regulatory strategic development to advance global operationsManage of guide junior members of staff as requiredThe preparation and maintenance of the product information – SmPCs and updates to PILs The successful candidate will:

Have a relevant science degree or equivalentProven experience with UK, EU, and Global regulatory requirementsHave a strong understanding of relevant regulatory requirements (including MAAs)Strong technical experience in writing and authoring eCTD/CTD sectionsComprehensive knowledge of current CMC and ICH regulatory requirements as well as GMP standards Regulatory Affairs RA Head of Regulatory Affairs GMP Pharmaceutical Regulatory Submission Dossiers EU Global MHRA FDA Good Manufacturing Practice CTD Common Technical Documentation eCTD Electronic Common Technical Documentation Module 1 Module 2 Module 3 Module 4 Module 5 MAA Marketing Authorisation Application CMC Chemistry Manufacturing Controls IMPD Variations SmPC Summary of Product Characteristic PIL Product Information Leaflet