Regulatory Affairs & Quality Assurance Associate

Galderma

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profile Job Location:

Stockholm - Sweden

profile Monthly Salary: Not Disclosed
Posted on: 3 days ago
Vacancies: 1 Vacancy

Job Summary

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold 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 were unique and we embrace difference.

Whether its 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 isnt 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 aRegulatory Affairs & Quality Assurance Associateto 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 bachelors 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. Youll 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 youll 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.


Required Experience:

IC

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatologic...
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