
Dermatology Regulatory Expert
2 days ago
GALDERMA'S MISSION
We are committed to advancing dermatology for every skin story. Our innovative portfolio of premium flagship brands and services spans the full spectrum of the fast-growing dermatology market. We deliver exceptional outcomes in partnership with healthcare professionals.
We seek talented individuals who share our passion for making a meaningful impact on consumers, patients, and healthcare professionals. As a Regulatory Affairs & Quality Assurance Officer, you will play a critical role in ensuring the successful launch of new products while maintaining our existing portfolio.
About the Role: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. You will navigate regulatory landscapes and uphold quality standards, contributing to our mission of delivering safe and effective products to the market.
Key Responsibilities:- Manage the life cycle of our product portfolio, including pharmaceutical, cosmetic, and medical device products.
- Ensure accurate texts are included 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.
- 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.
- A good understanding of the pharmaceutical industry across the Nordic country cluster.
- Pharmacist degree or bachelor's 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 problem-solving skills.
- Ability to prioritize and manage multiple projects simultaneously.
- Thriving in dynamic and evolving environments.
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