Abbvie

Oslo

Are you passionate about driving changes that impact patients’ lives worldwide?
At AbbVie, our mission is focused on advancing innovative therapies and placing patient well-being at the heart of everything we do. We are now seeking another talented professional to join our Regulatory Affairs team.
As a member of Regulatory Affairs, you’ll contribute by managing regulatory activities ensuring new product registrations and maintaining existing marketing authorizations, collaborate with cross-functional experts, and make meaningful contributions to regulatory strategy and compliance -- all with patients in mind. If you’re committed to excellence, eager to make a real-world difference, and looking for a place where your work genuinely matters, AbbVie’s Regulatory Affairs is your next career destination.
The candidate will join the Scandinavian Regulatory team as Regulatory Affairs Manager for Norway, reporting to the Head of Regulatory Affairs Norway and Denmark.
This is a temporary position, estimated start 1 Nov 2025 and ending on 31 Dec 2026, with the possibility of extension due to maternity leave.
<h4 class="navds-heading navds-heading--xsmall navds-typo--spacing">Responsibilities include:</h4>
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Lead assigned products regulatory activities in Norway/Scandinavia in collaboration with the Head of Regulatory Affairs
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Manage new product registrations, variations, and maintain compliance of marketing authorizations
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Translation of Product Information and Instruction for Use within given timelines
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Artwork development in Electronic Review System (review and approval).
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Prepare and/or update the abbreviated version of the SmPC (Felleskatalogen)
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Update and maintain AbbVie regulatory databases and tracking logs.
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Ensure correct and timely communication with internal stakeholders of new Product Information and abbreviated version of the SmPC used in marketing material.
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Collaborate with Scandinavian/affiliate brand teams, local regulatory authorities, and other stakeholders to advocate for regulatory strategies, objectives, and timelines.
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Promotion control -- review and approval of marketing material. Ensure promotional material developed is in line with local regulation and Pharma Code of Conduct (local/Scandinavian).
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Engage with regulatory policymakers and professional associations to stay informed about trends and changes in national and EU legislation.
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<h4 class="navds-heading navds-heading--xsmall navds-typo--spacing">Qualifications:</h4>
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Cand. Pharm., M.Sc., Cand. Scient or equivalent
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Experience in Regulatory Affairs and/or promotion control, preferred but not required
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Genuine interest in developing and maintaining expert knowledge for Regulatory Affairs and assigned therapeutic area/product in general
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Genuine interest paying attention to details, work structured and follow timelines
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Fluency in written Norwegian to facilitate translations of product information and instructions for use
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Excellent written and spoken communication in English
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Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
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Collaborative, team-oriented approach, able to develop and support relationships across the organization
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Project management skills, and the ability to get things done
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Flexible and able to deal with ambiguity
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High customer orientation
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<h4 class="navds-heading navds-heading--xsmall navds-typo--spacing">We offer:</h4>
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A passionate focus on the professional and personal development of our employees
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Great career opportunities in a large, international company
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A large Scandinavian Regulatory team with highly skilled employees
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A dynamic workplace based on respect, where involvement from our employees is strongly encouraged
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A stimulating and flexible workplace where life-navigation is an integrated part of our work culture
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Competitive benefit package
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Please send your application as soon as possible, and no later than Sept 12th. 
We review applications and schedule interviews on an ongoing basis.
If you have any questions regarding the position, please reach out to Inger Lise Gruener (Head of Regulatory Affairs, Norway and Denmark).

Temporary role open in the AbbVie Regulatory Affairs team