Regulatory Affairs Officer to Astellas Pharma

Poolia is recruiting a proactive and structured Regulatory Affairs Officer to Astellas Pharma.

You will be based at the Nordic Head Office in Copenhagen (Kastrup). The position is full-time. You are initially offered a fixed-term contract for 14 months.

Have you recently graduated from university or you have a couple of years of relevant experience? Are you interested in the pharmaceutical industry and do you want to join a successful company?

Please apply as soon as possible.

Job description
You are offered a challenging and developing position in an international environment. As Regulatory Affairs Officer you will be a part of a successful, expanding company with a very promising and delivering pipeline. The regulatory function in Copenhagen (Kastrup) consists of a strong team that you will be part of.

Your areas of responsibilities will be:

- Maintenance of Astellas registered products in the Nordic and the Baltic region

- Prepare the follow-ups on variations for responsible products

- Review and approval of regulatory parts of the promotional material

- Maintain packaging material in compliance with regulations in Denmark, Finland, Iceland, Norway, Sweden and the Baltics

- Ensure that legal requirements are fulfilled in accordance with national requirements and regulations

You will internally work closely with Quality, Logistics, Sales, Marketing and the Regulatory function at the Head Quarter in the Netherlands.

The position reports to the Head of Regulatory and Quality.

Qualifications
You probably have a Bachelor’s or Master’s degree (Pharmacist, Chemistry, Biochemistry, Biomedicine, Quality or in other relevant area). We believe that you either have graduated recently or that you have 1-5 years of relevant experience. Previous experience from regulatory, quality or compliance is valuable but not a prerequisite.

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

In order to be successful in the position we believe you are proactive, analytical, structured and goal-oriented with an international mindset. You are thorough and have a high attention to details. It is important that you are flexible, team-oriented and able to work cross-functionally. You are also able to work efficiently and to meet deadlines.