Regulatory Affairs Associate – Fixed-term contract

AstraZeneca

. Drive timely management of regulatory submissions and approvals across all Nordic countries .

Posted 10/22/2026full-timeStockholm • SwedenJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance management within the pharmaceutical industry, with a strong focus on product lifecycle activities and stakeholder collaboration. Proficient in managing artwork and labelling projects while ensuring adherence to relevant legislation and internal policies.

Highest-signal resume keywords

Regulatory Submissions ManagementPharmaceutical Industry ExperienceKnowledge of Labelling RegulationsStakeholder Relationship BuildingFluency in English and Nordic Languages

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProduct Lifecycle ManagementArtwork ApprovalElectronic SubmissionsRegulatory ComplianceSOP DevelopmentRegulatory Legislation KnowledgeProject ManagementBusiness AcumenRegulatory Toolbox

Soft Skills

Influencing SkillsCommunication SkillsRelationship BuildingPlanning SkillsProcess Improvement

Tools & Technologies

Gazelle

Certifications & Qualifications

University Degree in Pharmacy or Equivalent

Industry Keywords

Regulatory AffairsNordic CountriesHealth AuthoritiesCompliancePharmaceutical Regulations

About the role

Key responsibilities & impact

Drive timely management of regulatory submissions and approvals across all Nordic countries
Manage smooth product lifecycle activities to ensure products are compliant and available
Develop and manage artwork and labelling projects in Gazelle for Nordic products
Approve artwork for accuracy, compliance, and supply readiness
Prepare and compile regulatory submissions for assigned products
Monitor labelling regulation trends and translate them into updates, guidance, and streamlined processes
Communicate with national health authorities on pending issues and evolving requirements
Lead company-specific regulatory questions and shape compliant pathways
Collaborate with Nordic and global regulatory colleagues, Supply, Operations, Logistics, and other stakeholders
Record submission lifecycle information and maintain electronic archives
Own and update specific SOPs and ensure compliance with external requirements and internal policies
Drive ways-of-working improvements, contribute to department development, and share best practices

Requirements

What you’ll need

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

Benefits

Comp & perks

Employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity
Reasonable adjustments/accommodations to help all candidates perform at their best