We are looking for an Assistant/Documentation Officer for 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.

The Regulatory Affairs department is responsible for developing registration strategies and managing the evaluation and compilation of the documentation required for the approval of new products, new uses for products, as well as renewals and amendments.

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

Position Overview: 
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 
As an Assistant/Documentation Officer, you will work with a variety of tasks including the publication of registration documentation.

You will collaborate with the department's Regulatory Affairs Managers and project groups to compile documentation; new applications, amendment applications, response packages, within European and worldwide regulatory authorities, considering internal SOPs and using regulatory IT tools. The work includes compilation, hyperlinking, validation, and distribution. The tool eCTD-manager is used for the publishing work.

Other tasks include maintenance of the registration database, archiving and ordering of certificates and registration samples, as well as notarization/legalization of documents and certificates and worldwide shipping.

About you

You enjoy compiling large amounts of documents, detail-oriented, keeping order, and completing tasks with absolute adherence to deadlines. As a person, you are meticulous, independent, and stable and can prioritize among tasks. You are unpretentious, solution-oriented, and collaborative.

You have:

• Professional experience in the field of Regulatory Affair as assistant/Documentation Officer.
• Post-secondary secretarial education, such as medical secretary, medical documentarian, Office Management Specialist, Archive Specialist or equivalent, preferably with experience in handling and publishing registration documentation and databases.
• Strong IT skills and are eager to learn new tasks.
• Excellent knowledge of Microsoft Office.
• Good knowledge of English and Swedish, both spoken and written.

About the position
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.

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.