About Fresenius Kabi AB
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. In the field of biosimilars, we develop products with a focus on oncology and autoimmune diseases. Our products and services are used to help care for critically and chronically ill patients. With our corporate philosophy of "caring for life", we are committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.
I.V. Generic Drugs, Infusion Therapies, Clinical Nutrition (enteral and parenteral), Medical Devices, Transfusion Technology Products, and Biosimilars
Fresenius Kabi employs more than 36,000 people worldwide. In 2017 the company reported sales of more than €6.3 billion.
Fresenius Kabi is a global leader in our business segments. We offer employees of diverse cultures and backgrounds a wide range of fulfilling and challenging career and personal growth opportunities, both domestically and internationally. We work together in a spirit of partnership, personal commitment and integrity to create value.
• world-class, dedicated teams
• an open-minded, creative, can-do culture
• a variety of opportunities to grow with the business
• the chance to make a difference in patients’ quality of life
For more information, visit the company´s web sites at http://www.fresenius-kabi.se
Regulatory Affairs Manager -Sweden
Position: Regulatoy Affairs Manager -Sweden
Company: Fresenius Kabi AB
Location: At the office in Uppsala
Reports to: QA-RA Manager, Nordics
Regulatory Affairs Manager -Sweden
We are looking for a Regulatory Affairs Manager, responsible for Regulatory Affairs in the Swedish affiliate, for product within areas; Enteral Nutrition, Parenteral Nutrition, Fluids, Disinfectants, Medical Devices, Pharmaceuticals and Biosimilars. You will be responsible for preparation and submission of applications to Medical Product Agency, and Livsmedelsverket (Enteral Nutrition). Other things are to coordinate/contribute to arrange translations of SmPCs, PLs and labelling texts to Swedish, write PLs for national products, if applicable and review mock-ups before submission and implementation of art-work.
We are looking for an individual with experience from a regulatory role in the Pharmaceutical Industry who would like to develop into a regulatory role with a broad responsibility.
• Master in Pharmacy, Biomedicine or similar education
• Experience from the Pharmaceutical Industry
• Previous experience in regulatory affairs
• Experience in creating and filing new drug applications for approval is a merit
• Good knowledge in Microsoft Office and working in and with various databases
• Fluent in English and Swedish, oral and written
• Experience from pharmacovigilance, compliance and/or quality is a merit
• High integrity
• Flexible and adaptable
• Targeted, structured and energetic
• Ability to work under pressure to meet strict deadlines
• Ability to see opportunities for improvements
• Possess a strong sense of responsibility
• High level of self-motivation with the ability to work independently and as part of a team
• Able to build relationship
• Excellent communication skills
• Confident and self-dependent
• Positive “can-do” attitude
Opportunities with the role
• The possibility to work for a growing company with a high growth rate and very good profitability
• Responsible for the Regulatory Affairs in Sweden
• A possibility to work with many different products (Parenteral-/Enteral Nutrition, Medical Devices, Pharmaceuticals, Biosimilars)
• Good possibilities to personal and professional development
• Good benefits package
For further information about the position, please contact Marta Frick, Senior Recruitment consultants at PeakSearch.
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