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Role Overview

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

Requirements

A degree in pharmacy or another relevant life science discipline
Several years of experience in regulatory affairs for pharmaceuticals
Experience from industry, a regulatory authority or consulting
Experience with regulatory submissions or regulatory project coordination
Excellent communication skills in English and Swedish

Benefits

Flexibility to work from home or the office,
Professional development opportunities

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Open Positions (1)

Management

Senior Regulatory Consultant, RegSmart Life Science