Senior Manager, Nordics Regulatory Affairs Alexion
Senior Manager, Nordics Regulatory Affairs Alexion
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Job Description
Are you ready to make a significant impact in the world of regulatory affairs
As a Senior Manager Nordics Regulatory Affairs youll play a pivotal role in ensuring the regulatory compliance of Alexions commercialized drugs in the Nordics region. Working closely with the CENE (Central and Northern Europe) Regulatory Affairs and Quality team youll be the vital link between Alexion and the National Competent Authority (NCA) driving regulatory submissions and discussions in the Nordics region. Your expertise will ensure that Alexions authorized products meet all applicable regulations and company standards. Are you prepared to lead and innovate in this dynamic environment
Reporting directly to Head of CENE Region Regulatory Affairs and Quality youll partner with Patient Safety and Customer Operations Market Access Medical Affairs and Commercial teams.
This position is based in our Stockholm office.
What youll do:
The key responsibilities of the Senior Manager Nordics Regulatory Affairs at Alexion include managing local regulatory compliance for all commercialized products in the Nordics serving as the main liaison between Alexion and national regulatory authorities managing local implementation activities of centrally authorized products and implementing post-approval commitments such as educational materials / aRMMs. The role involves coordinating with internal stakeholders ensuring packaging material and labelling meet local requirements maintaining accurate regulatory documentation and reviewing promotional materials according to company procedures. Additionally this position monitors regulatory changes manages vendors and budgets supports clinical trials and access programs participates in audits and provides training and leadership for regulatory affairs contractors.
Essentials for the role:
- Experience:35 years in pharma/biotech with a focus on regulatory affairs in the Nordics.
- Expertise:In-depth understanding of Nordic and EU regulatory frameworks along with hands-on experience in regulatory submissions.
- Skills:Demonstrated proficiency in document and artwork management systems strong attention to detail independence and effective time management under pressure.
- Collaboration:Excellent social skills able to build productive cross-functional relationships internally and externally.
- Languages:Fluent in English and at least one Nordic language (Swedish Danish Norwegian or Finnish).
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique ad ambitious world.
I&D
At AstraZeneca we embrace an ethos where work means more than just a job. Our closeness to patients fuels our passion for innovation and drives us to create meaningful value every day. With a rapidly expanding portfolio we offer an entrepreneurial spirit combined with the strength of a global biopharma leader. Here diversity is valued inclusion is championed and new ideas are celebrated. Join us in making a profound impact on patients lives while growing your career in a supportive environment.
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 Englishlatestby the 16th of October 2025!
To find out more:
Our social media Follow AstraZeneca on LinkedIn: social media Follow Alexion on LinkedIn
Date Posted
02-okt.-2025Closing Date
16-okt.-2025Our 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.Required Experience:
Senior Manager
Employment Type
Full-Time
