Specialist Regulatory Affairs Pharma

Fresenius Kabi is a leading global health care company that offers life-saving medical devices and medicinal products. At Fresenius Kabi we are dedicated to excellence with no compromise on quality, teamwork through respectful collaboration, serving patients beyond expectations, innovating healthcare by learning with our customers and partners, and acting today for a better tomorrow while being mindful of future needs and resources, all grounded in over 100 years of heritage. One of our units is specialized in the development, manufacturing, and commercialization of high-quality Parenteral Nutrition & Keto-analogues. Our mission is to offer the right solution for the diverse needs of our customers & critically and chronically ill patients to improve their quality of care.

We are looking for a dedicated and knowledgeable Specialist Regulatory Affairs Pharma to join our growing team and contribute to the development of our portfolio. 

Position Overview: 

We are seeking a curious and proactive Specialist Regulatory Affairs Pharma to join our team. In this role, you will support the Regulatory Affairs department with tasks related to drug approval in the Regulatory Affairs Parenteral Nutrition & Keto-analogues, Pharma & Nutrition. The ideal candidate will possess strong communication skills, and a passion for quality. 

Key Responsibilities 

Support the Regulatory Affairs Manager with:

• Support preparation of approval dossiers for new products, considering the regulatory environment, relevant regulations and guidelines, internal SOPs and using regulatory IT tools.
• Coordination of registration procedures worldwide and support local branches in preparing new submissions, handling deficiency letters.
• Maintenance of worldwide drug registrations (variations and renewals)
• Correspondence with respective authorities.

• Independent processing of dossiers, document creation and database maintenance (in the relevant systems).
• Independent organization of legalized/notarization/apostillation of documents, cost billing and worldwide shipping.
• Independent coordination of collaboration with Shared Service Center.

Key Requirements: 

• Several years of professional experience in the field of Regulatory Affairs
• Pharmacy Technician, Medical Technical Assistant, medical documentarian, Office Management Specialist, Archive Specialist
• Independent and responsible working
• Structured working style, detail-oriented, team player, flexible, careful work even under time pressure
• Absolute adherence to deadlines
• Very good communication skills
• Very good knowledge of the English language in both spoken and written form
• Good IT skills

What We Offer: 

• A dynamic, collaborative, and supportive work environment. 
• Opportunities to grow within a leading global pharmaceutical company. 
• Competitive salary and benefits package. 
• Exposure to exciting and impactful projects. 

If you are passionate about the pharmaceutical industry and ready to take the next step in your career and be part of our team, we would love to hear from you!  

About Us

We are a growing company with approximately 1,000 employees in Sweden and over 40,000 employees worldwide. Our pride in our products permeates the entire organization. In our employee surveys, colleagues, development opportunities, and the family-like atmosphere are highlighted as some of the best aspects of working at Fresenius Kabi.

Being part of Fresenius Kabi means being part of an environment with a promising future. We believe in our people and are passionate about the development of all our employees. You will have great opportunities to influence what that development looks like.
Fresenius Kabi has also, for the third consecutive year, been named a Career Company, making us an attractive employer in Sweden thanks to our unique career opportunities.
Our global organization offers a wide variety of paths to choose from as part of your future development.

Contact
If you would like to know more about the position, you are welcome to contact the hiring manager, Anabela Godinho, at anabela.godinho@fresenius-kabi.com.

For union contacts, you can email unionen-klubben@fresenius-kabi.com for Unionen or akademikerforeningen@fresenius-kabi.com for the Academic Association.

We warmly welcome your application! Our recruitment process includes tests, interviews, reference checks, and a background check. During the interview, we kindly ask you to present your diploma and relevant certificates. For the final candidate, a pre-employment health screening will be conducted by our occupational health service.
Please note that selection will begin after the application deadline due to the holiday period. Unfortunately, we do not accept applications via email or post.