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Regulatory Affairs & Quality Assurance Associate

icon building Company : Galderma
icon briefcase Job Type : Full Time

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Job Description - Regulatory Affairs & Quality Assurance Associate

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

At Galderma, we’re unique and we embrace difference.

Whether it’s the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products, or our commitment to recognising and rewarding people for the contribution they make – working here isn’t like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Regulatory Affairs & Quality Assurance Associate

Location: Stockholm City - Hybrid

About the Role

We are seeking a Regulatory Affairs & Quality Assurance Associate to join our team, focusing on the Nordic region. This is a shared position, with 50 % dedicated to Regulatory Affairs (RA) and 50 % to Quality Assurance (QA), reporting to the Regulatory Affairs Manager Nordics. It is a crucial role in ensuring the successful launch of new products, while also maintaining the existing portfolio. You will play a key role in navigating regulatory landscapes and upholding quality standards, contributing to our mission of delivering safe and effective products to the market.

RA Key Responsibilities:

  • Manage the life cycle activities of the product portfolio, including pharmaceutical (RX and OTC), cosmetic, and medical device products across all Nordic markets (SE, DK, NO, FI, IS).
  • Support product launches across all product categories.
  • Maintain national product catalogues such as FASS, Felleskatalogen and DKMAnet.
  • Review and approve labelling and artworks, ensuring compliance with national regulations.
  • Provide proactive regulatory advice aligned with business strategies and act as a regulatory affairs contact point for authorities and internal stakeholders.
  • Contribute to shaping the regulatory environment in the Nordics.

QA Key Responsibilities:

  • Establish and maintain quality systems, including records management.
  • Deputize for the Responsible Person in delegated pharmaceutical activities.
  • Manage product complaints and returns.
  • Handle temperature excursions during transportation and assess the impact on product quality.
  • Manage shortage notifications to health authorities where required.
  • Support good relationships with health authorities in the Nordic region and contribute to fostering a quality culture.

Key Requirements:

  • Pharmacist degree or bachelor's degree in pharmaceutical science or equivalent by experience.
  • At least 3-5 years of experience in Regulatory Affairs from an affiliate perspective. Experience in pharmaceutical Quality Assurance, GDP.
  • A good understanding of the pharmaceutical industry across the Nordic country cluster (SE/DK/NO/FI/IS)
  • Fluency in English and Swedish. Knowledge of any other Scandinavian language would be an asset.
  • Ability to prioritize and manage multiple parallel tasks.
  • A positive team player, thriving in small dynamic and evolving environments.

What we offer in return

At Galderma, you will have the opportunity to lead regional operations across multiple markets and gain visibility across both local and global teams. You’ll be part of a collaborative, cross-functional environment with the autonomy to make a real impact on the business.

We offer a hybrid working model, professional development opportunities, and the chance to be part of a global organization committed to operational excellence and continuous improvement.

Next Steps

If your application is successful and your profile is a match, you will be invited for:

A first virtual conversation with the recruiter. A virtual interview with the Hiring Manager. A final panel interview with the extended team.

Our people make a difference

At Galderma, you’ll work with people who are like you – and people who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos create the perfect environment for people to thrive and excel in what they do.

Original job Regulatory Affairs & Quality Assurance Associate posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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