Senior Regulatory Consultant, RegSmart Life Science
SwedenCompetitiveHybrid0 applicants
About this role
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.
Responsibilities
- 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-time and permanent, based in Uppsala or remote/hybrid, with start date upon agreement.
Requirements
- We are looking for someone who has:
- 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
- You are likely structured, analytical, collaborative and comfortable working independently in a consulting environment.
- Application and information
- RegSmart is working with Search4S in this recruitment. Please contact Anna Rennermalm for more information. Interviews will be held on an ongoing basis.
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