Regulatory Affairs Associate - Fixed-term contract (Nordics) - Nordic Marketing Company

Job description

*Are you ready to transform complex EU labelling and regulatory processes into faster, safer access to medicines for patients across the Nordics? Can you spot regulatory risks early and turn them into clear, pragmatic solutions that move the business forward?* *Then this could be your next step with us at AstraZeneca!* Our AstraZeneca Nordic Marketing Company employs around 550 people and has offices located in Copenhagen, Stockholm, Oslo, and Espoo. AstraZeneca Nordic is a recognized leader in its core therapy areas and aims to improve the lives of millions of people. This is an area where you are free to grow - you are encouraged to challenge traditional ways of working and exercise your curiosity. We drive innovative science, deliver key launches, build close collaboration and partnerships within health care. **Introduction to role:** In this role, covering all Nordic countries, you will drive timely management of regulatory submissions and approvals, and smooth lifecycle management to ensure that our products are compliant and available. You will be a driving force behind artwork and labelling excellence in Gazelle, regulatory submissions of high quality, and engagement with Nordic authorities. Working closely with Nordic and global regulatory colleagues, Supply, Operations, and Logistics, you will align decisions and actions so that every update, batch, and pack change reaches patients without delay. This role is a maternity leave cover, with a fixed term contract until end of March 2028. You can be located in any of our Nordic offices (Espoo, Copenhagen, Oslo, Stockholm, Tallin), and you are expected to be on-site three days per week. **Accountabilities:** - Artwork and Labelling Leadership (Gazelle): Develop and manage new and lifecycle artwork projects in Gazelle to company standards for all Nordic products and approve artwork to ensure accuracy, compliance, and readiness for supply. - Launch and Lifecycle Management: Prepare and compile regulatory submissions for assigned products to secure rapid, high-quality approvals that enable timely launches and ongoing market supply. - Regulatory Intelligence and Adaptation: Monitor trends and changes in labelling regulations and translate them into proactive updates, guidance, and streamlined internal processes. - Authority Engagement: Communicate with national health authorities on pending issues and evolving requirements; lead AstraZeneca-specific regulatory questions and shape practical, compliant pathways. - Cross-Functional Collaboration: Partner closely with internal and external stakeholders to align plans, resolve constraints, and safeguard patient access. - Data Integrity and Documentation: Record submission lifecycle information in accordance with current standards and procedures; maintain orderly electronic archives that make information easy to find and use. - SOP Ownership and Compliance: Own and update specific SOPs; ensure AstraZeneca texts, practices, and materials meet external requirements and internal policies; deliver right-first-time outputs in line with legal and procedural standards. - Team Contribution: Drive ways-of-working improvements, contribute to department development, and share best practices that raise team effectiveness. **Essential Skills/Experience:** - University degree in Pharmacy or equivalent. - Experience from pharmaceutical industry. - Knowledge of the contents/formatting of regulatory submissions, specifically electronic submissions and product life cycle of regulatory submissions. - Solid business acumen and a good RA toolbox to apply. - Good knowledge of relevant legislation requirements and procedures. - Demonstrated experience with Regulatory work. - Excellent knowledge of English and at least one of the Nordic languages. - Good at influencing and building relationships with stakeholders. - Ability to plan, communicate and drive processes and projects all the way to the finish line. **Inclusion & Diversity**We are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity**.** **Why AstraZeneca?**We at AstraZeneca see every opportunity, no matter how small, as a beginning of something big. We are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energised and rewarded for their ideas and creativity. We strive to unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. Join us in our unique and ambitious world. **So, what is next?**Are you already imagining yourself joining our team? Great, because we cannot wait to hear from you! Welcome with your application, in English, **latest by the 4th of November 2026!** *Applications will be reviewed continuously throughout the application period.* **Where can I find out more?**Follow AstraZeneca on LinkedIn: Inclusion & Diversity: [Inclusion and diversity](https://www.astrazeneca.com/careers/great-place-to-work/inclusion-and-diversity.html)Career site: [The Nordic Marketing Company](https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/stockholm.html) **Date Posted** 22-okt.-2026 **Closing Date** 04-nov.-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.