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Anna-Karin brings over 25 years of experience in the pharmaceutical industry, including 15 years dedicated to Regulatory Affairs. Her expertise spans multiple areas, including module 3/CMC, as well as regulatory work at both headquarters and affiliate levels in small and large pharmaceutical companies. Specializing in the post-marketing phase, Anna-Karin has a deep understanding of customer needs in Regulatory Affairs at global, Nordic, and national levels. Additionally, she brings valuable experience in the ethical landscape of marketing compliance.
With 25 years of experience in the pharmaceutical industry, Margrethe is a science-driven Regulatory Affairs expert with deep expertise across the product life cycle - from early clinical stages to life cycle management. Specializing in pre-approval activities for small and mid-sized pharmaceutical companies, Margrethe has collaborated with regulatory authorities across Europe, the US, and Japan. Additionally, she has experience with generics and brings 9 years of expertise in CMC. Her strong project management and leadership skills make her a valuable asset in regulatory strategy and execution. Beyond her industry role, Margrethe shares her knowledge as a lecturer at Atrium, a leading life science course provider that collaborates with the University of Copenhagen.
Since 1986, Jaana has held various roles in the pharmaceutical industry, including eight years dedicated to establishing ISO 9001-compliant quality systems in the chemical sector. With +20 years of experience in regulatory affairs, Jaana has successfully managed product registrations worldwide. Her expertise extends beyond EU regulatory processes to include Asia, the Middle East, and South America. Jaana understands the complexities of working across diverse cultures and regulatory frameworks. Having worked with both global corporations and micro-sized companies, as well as within a health authority organization, Jaana has developed a deep and well-rounded understanding of regulatory affairs, always with a strong focus on quality and patient safety.
PharmaRelations
Frösundaviks Allé 1
169 70 Solna
Sweden