Regulatory Affairs Manager

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 submissions
• Review CMC dossiers and components (e.g MAAs, deficiencies, variations, IMPD/IND CMC components)
• Proactively contributing to regulatory strategic development to advance global operations
• Manage of guide junior members of staff as required
• The preparation and maintenance of the product information - SmPCs and updates to PILs

The successful candidate will:

• Have a relevant science degree or equivalent
• Proven experience with UK, EU, and Global regulatory requirements
• Have a strong understanding of relevant regulatory requirements (including MAAs)
• Strong technical experience in writing and authoring eCTD/CTD sections
• Comprehensive 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