Regulatory Affairs Quality Assurance Officer Stockholm City

Galderma is the emerging pureplay dermatology category leader present in approximately 90 countries. We deliver an innovative sciencebased portfolio of premium flagship brands and services that span the full spectrum of the fastgrowing 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.

About the Role

We are seeking a Regulatory Affairs & Quality Assurance Officer 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. This role is crucial 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 of the product portfolio including pharmaceutical (RX and OTC) cosmetic and medical device products.
• Ensure accurate texts are included for products in standard reference databases such as FASS and Pharmaca Fennica.
• 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.
• 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:

• At least 2 years of experience in Regulatory Affairs in the field of medicinal products and at least 2 years of experience in pharmaceutical Quality Assurance such as manufacturing or distribution Quality Assurance.
• A good understanding of the pharmaceutical industry across the Nordic country cluster (Sweden Denmark Finland Norway Iceland). Experience with medical devices and cosmetics is preferred.
• Pharmacist degree or bachelors degree in pharmaceutical science or equivalent by experience.
• Fluency in English and Swedish. Knowledge of any other Scandinavian language would be an asset.
• Strong analytical and problemsolving skills.
• Ability to prioritize and manage multiple projects simultaneously.
• Thriving in dynamic and evolving environments.