Senior Regulatory Consultant, RegSmart Life Science

Job description

Are you an experienced regulatory professional who enjoys combining strategic thinking with hands-on regulatory work? At RegSmart you will support pharmaceutical companies in complex regulatory processes and contribute across the full regulatory lifecycle. The role As a Senior Regulatory Consultant, you will provide strategic and operational regulatory support to pharmaceutical clients. You will work on multiple projects in parallel and collaborate closely with both client teams and experienced regulatory specialists at RegSmart. Your work may include: Advising on regulatory development strategies and approval pathways Coordinating regulatory activities in EU and US development programmes Supporting procedures such as Scientific Advice, PIP and orphan designation Contributing to or leading marketing authorisation applications (MAA/NDA) Preparing and coordinating regulatory documentation, submissions & publishing, including eCTD and IRIS. Managing variations and other post-approval regulatory activities Depending on your interests and experience, the role may also include medical writing, pharmacovigilance activities or representing RegSmart at industry events. The position is full-...