Regulatory Affairs Officer to Astellas Pharma

Poolia is recruiting a communicative and structured Regulatory Affairs Officer to Astellas Pharma in Copenhagen (Kastrup). Are you a Regulatory Affairs professional who would like to be close to the market and work in a team with the common mission to deliver high-quality medicines to patients? Then this full-time position could be of great interest to you.

Please apply as soon as possible.

JOB DESCRIPTION

You are offered a challenging and developing position in an international environment. You will work with a professional and dedicated team.

As Regulatory Affairs Officer you will be a part of a successful, expanding company with a very promising and delivering pipeline.

The Regulatory Affairs Officer will ensure efficient and timely regulatory processes with successful launches and lifecycle management. Your role will include providing regulatory expertise to support the organization, ensuring that our products meet the regulatory requirements with the focus on patients access to safe medicines.

You will coordinate and execute regulatory tasks at a marketing company for Denmark, Sweden, Norway, Finland and Iceland. Your areas of responsibilities will be:

• Responsibility for regulatory activities to ensure timely submissions, successful launches and lifecycle management
• Providing operational regulatory input and guidance to stakeholders and in cross-functional teams
• Understanding the EU and Nordic regulatory procedures and apply this knowledge in you daily work as well as when strategizing long term
• Ensuring product information, packaging material and promotional material meet external requirements, regulations and Astellas Pharma’s policies Work within and across the therapeutic areas to contribute in business decisions with regulatory insights and understanding of the regulatory framework

You will work in a multinational environment and interact with colleagues in Marketing, Sales, Quality, Logistics and the Regulatory function at the Head Quarter in the Netherlands.

The position reports to the Senior Director Regulatory Affairs.

QUALIFICATIONS

You have a Master’s degree in Pharmacy from a Danish university (cand.pharm.).

A minimum of 1-2 years’ experience in the pharmaceutical industry is required, preferable in a regulatory position. You have the necessary knowledge of the regulatory landscape and procedures within the Denmark and the other Nordic countries.

Fluency in speaking and writing Danish and English is a prerequisite for the position. You also have a good ability to understand Swedish and Norwegian.

You can communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and sometimes a large volume of work. You can work both alone and as part of a team.

ASTELLAS PHARMA

Astellas Pharma is a global company, originating in Japan, focusing on improving human health around the world by providing innovative and reliable drugs. We are mainly active in the fields of urology, oncology, transplantation, immunology and nephrology. Astellas vision is to always be on the forefront of health development and create added value for patients through innovative research and science.

Astellas Pharma is represented throughout the Nordic region and has its Nordic office in Copenhagen. We are approx. 150 dedicated employees and market prescription drugs in Sweden, Denmark, Norway, Finland and Iceland.

Astellas need honest and tolerant people who dare to be themselves. People who value diversity and who feel at home in a company that prioritizes ethical behavior and social and environmental responsibility. We all have the responsibility to develop a culture that we can thrive in - and we believe that people thrive best when they are allowed to be themselves. We are a workplace with all kinds of people and our strength is that we do not resemble each other. Common to all of us is that we help each other and do not give up.

CHANGING TOMORROW™ is the heart of our culture - from Tokyo to Reykjavik. In practice, this means that all employees, regardless of where they are in the organization, should work to ensure a better tomorrow for patients worldwide. For more information, visit our website www.astellas.eu