Regulatory Affairs Manager Scandinavia to medac Nordic

Poolia is recruiting analytical, structured and collaborative Regulatory Affairs Manager to the Nordic headquarter in Malmö of medac in “Hyllie The Point”. Are you team player with a keen interest in regulatory affairs? Would you like to work both with a strategic and operational focus in collaboration with the HQ in Germany? Then this full-time position could be of great interest to you.

Please apply as soon as possible.

About the position
You are offered a challenging and developing position in an international environment. You will work with a professional and dedicated team on a Nordic and European level.

The position will be part of the Operations team and you will work closely with our supply chain, sales, marketing, and finance functions. There will be regular interactions with the European HQ departments in Germany.

Your main responsibilities and accountabilities will be:

• Support the development, review, and compilation of documentation for maintenance of registered licenses in the Scandinavian market, such as change applications and renewals
• Support in the registration of new products in the form of translation of product information, review and approval of labeling materials and marketing materials
• Support for the regulatory department at our head office for the products where they are MAH, and the product is sold in the Scandinavian market
• Update of internal registration documents / databases and various product registers such as FASS, Felleskatalogen and DKMAnet
• Manage the application and maintenance of Scandinavian VNRs.
• Support the development, review, and compilation of documentation for maintenance of technical documentation
• Regulatory support for the company.
• Develop, review, and implement local SOPs within regulatory and safety
• Local responsible person for pharmacovigilance
• You will also act as Deputy Responsible Person for the GDP license

Some travel will be required in Scandinavia and to Germany.

You will report to the Head of Quality, Regulatory and Safety.

Your profile
We believe that you have at least 1-3 years of relevant experience in the pharmaceutical industry is required, preferable in a regulatory position. Apart from a strong English knowledge you are required to be fluent, both verbal and written, in either Swedish, Danish, or Norwegian.

We value previous experience of working in a cross Nordic environment with understanding of the different legal requirements. You have the necessary knowledge of the regulatory landscape and procedures within at least one Scandinavian country.

You need to be well-versed in Microsoft Office products and knowledge of information systems and tools is a distinct advantage.

The successful candidate for the position is analytical, demonstrates ownership, is creative, a team player and flexible. You are curious, willing to learn new things and have an inner drive of finding ways to solve challenges within your area of responsibility. On top of this, you have high integrity and a good judgment.

You also must have the ability to build collaborative relationships both inside and outside the company. We also value project coordination abilities. Excellent communication and presentation skills, both verbal and written, are also an advantage.

About the organisation
medac GmbH is a global, German owned pharmaceutical company, which specializes in the treatment and diagnosis of oncology, urology, autoimmune diseases, and fibrinolysis. With over 1700 employees in 18 countries worldwide, we are always striving to continue with our specialist research and development to enable us to expand our therapeutic portfolio, and in turn, improve the quality of patients’ lives.

Our portfolio contains both new, innovative medicinal products for rare diseases and established products. Specialist distribution and marketing teams ensure medac’s products are supplied directly to markets all over the world via our subsidiaries.

Please visit www.medac.se for further information.