Regulatory Affairs Specialist Nordics

Om jobbet

Location:Malmö, Hyllie
Company:Exeltis Sverige AB
Employment:Full-time, Permanent

Are you a structured, curious, and business-minded Regulatory Affairs professional looking to grow in an international environment? Exeltis is strengthening its Nordic affiliate and is now looking for aRegulatory Affairs Specialistwho will play a key role in ensuring regulatory excellence across Sweden, Denmark, Norway, Finland, and Iceland.

This is an opportunity to join a fast-growing organisation where you will collaborate closely with global regulatory teams and local Nordic functions and where your impact will be highly visible. While the role allows for remote work 1-2 days per week, regular office presence is valued to foster collaboration, learning and a strong team culture.

About Exeltis

Exeltis is part of Insud Pharma, a multinational pharmaceutical group with more than 45 years of experience and presence in over 55 countries. The Nordic affiliate promotes a broad Women's Health portfolio and is expanding into the CNS field. The culture is entrepreneurial, collaborative, and driven by innovation and growth.

The Role

AsRegulatory Affairs Specialist Nordics, you will manage lifecycle activities and regulatory operations across the Nordic region. The role requires a regulatory professional who can balance compliance and contributing through sound judgement, pragmatism and constructive collaboration.

You will work cross-functionally with PV, QA, Supply, and Marketing, and collaborate closely with global RA functions.

You will also be in charge artwork processes, product information updates, and post-approval commitments, while ensuring smooth collaboration with health authorities and local partners.

Key Responsibilities

• Manage national phase submissions and lifecycle updates across all Nordic markets (SE, DK, NO, FI, IS).
• Liaise with national competent authorities and maintain up-to-date regulatory intelligence.
• Support product launches and maintain national product catalogues.
• Initiate and approve artwork updates and ensure compliance with current guidelines.
• Implement and track post-approval commitments together with local PV teams.
• Work cross-functionally to enable the business while ensuring regulatory compliance.

Your Profile

We are looking for someone who brings the right mix of experience, mindset, and potential:

Qualifications

• Bachelor's degree in Pharmacy or another relevant scientific field.
• 3-5 years of experience in Regulatory Affairs with strong understanding of Nordic regulatory frameworks.
• Experience in lifecycle management, variations, and product information updates.
• An understanding of Pharmacovigilance is beneficial in this role and supports effective collaboration across the product lifecycle.
• Strong communication and coordination skills, with ability to manage several parallel tasks.
• Fluency in English is required; proficiency in a Nordic language is required, and Finnish language skills are an advantage.

Personal Attributes

• Proactive, pragmatic and solution-oriented - applies regulatory expertise in a pragmatic and structured way, contributing through reliable execution and thoughtful input that supports decision-making within the team.
• A curious and forward-thinking mindset, where innovation and constructive challenge through new ideas are actively encouraged and valued.
• Detail-oriented with strong ownership and ability to deliver on time.
• Positive team player who thrives in a small, fast-moving and evolving organisation.
• Comfortable stepping outside the traditional RA comfort zone when needed.

What you'll find here

• Broad exposure - collaboration with PV, QA, Supply and Marketing, plus touchpoints with an external RP.
• Global backbone, local agility - you will work locally with hands-on responsibilities, supported by established global processes, expertise and teams.
• Role that grows with the business - expanding portfolio (incl. CNS) creates natural headroom for development.
• Manager who values trust and pragmatism - partnership mindset and open, solution-oriented dialogue.
• Visible impact - a lean team where your work is noticed by both Nordic leadership and global RA.
• Hybrid flexibility - a modern, collaborative office in Hyllie, Malmö, combined with possibility of remote work.

Why This Role?

This role offers the opportunity to develop through innovation thinking, constructive challenge and continuous learning, including contributing ideas, participating in cross-functional initiatives and supporting the development of new ways of working - such as the use of AI - in close collaboration with the manager and the wider organisation.

The Recruitment Process - Your Application

PharmaRelations is managing this recruitment on behalf of Exeltis. If you believe your background and expertise align with the requirements, we encourage you to submit your application through the "Apply" button. We will review all applications with great care in our search for the right candidate. A kind reminder is that the application documents should not be sent via email. For questions regarding the position, you are welcome to contact Kristina Edholm ( kristina.edholm@pharmarelations.se ) or Stefan Lind ( stefan.lind@pharmarelations.se ).