
Medical Products Compliance Specialist
2 days ago
Advancing Dermatology Together
We are GALDERMA, a leader in the dermatology market. Our commitment to innovation, quality, and patient safety drives us to push boundaries and strive for excellence. As a Regulatory Affairs & Quality Assurance Officer, you will be part of our journey to advance dermatology for every skin story.
You will work closely with our Regulatory Affairs Manager Nordics to ensure the successful launch of new products while maintaining our existing portfolio. Your expertise in Regulatory Affairs and Quality Assurance will be instrumental in navigating regulatory landscapes and upholding quality standards.
About the Job:This role is ideal for individuals who possess strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to thrive in dynamic and evolving environments. If you are passionate about making a meaningful impact on consumers, patients, and healthcare professionals, this could be your dream job.
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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