Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences and rare diseases. Ipsen commercialize more than 20 drugs in over 115 countries, with a direct commercial presence in 30 countries worldwide.
In the Nordic countries, Ipsen is represented since 2006 with a Nordic office in Kista Science Tower outside Stockholm. In 2019, Ipsen was announced as the fastest growing pharma company in Sweden according to Läkemedelsmarknaden. Today we are about 55 employees in the Nordic region and we work mainly in the therapeutic areas of endocrinology, oncology (renal cell carcinoma, hepatocellular carcinoma, prostate cancer), neuromuscular diseases, and disease. We also have our Baltic marketing organization, with around 20 people, belonging to the cluster.
The Nordic Regulatory Affairs department currently has 5 employees and is expanding to 6. The primary focus for the Regulatory Affairs department is on regulatory affairs, quality assurance and pharmacovigilance. Due to the expansion we are now looking for a Regulatory Affairs Officer to the Nordic office in Kista Science Tower, Stockholm.
Scope of the role
As a Regulatory Affairs Officer at Ipsen you contribute to Ipsen’s growth in the Nordic region by maintaining and optimizing existing registrations for assigned Ipsen products and you should have in depth knowledge of national regulations and legislation for the Nordic countries, internal Ipsen regulatory processes and EU regulatory directives and guidelines.
- Maintain liaison with Ipsen Global Regulatory Affairs and ensure adherence to respective Ipsen global policies, procedures and guidelines.
- Represent Ipsen and be the contact person from a regulatory point of view to the Swedish, Finnish, Danish, Norwegian, and Icelandic local health authorities.
- Responsible for the regulatory life cycle management of an assigned product portfolio, including all regulatory variations as well as appropriate implementation of the changes.
- Responsible for keeping the labelling material for assigned products updated and in line with regulatory requirements in the Nordic countries.
- Responsible for input to the Ipsen Artwork database to progress, review and approve labels, leaflets and cartons requirement.
- Responsible for timely review and updates to the relevant Physicians’ Desk Reference (FASS, Felleskatalogen etc) for assigned products in the Nordic countries.
- Responsible for contacts and coordination with regulatory consultants and translators in the Nordic region.
- Regulatory review and approval of promotional materials.
- Responsible for tracking Product Complaints and Adverse Events from the Nordic region as back up to the Quality Manager and Pharmacovigilance Manager. into applicable database.
- Degree in Scientific discipline (Pharmacy, Chemistry, Biological Sciences) is preferred
- Substantial experience in a Regulatory Affairs team with very good knowledge of Nordics local legislation and guidelines.
- Good understanding of market dynamics and requirements in the Nordic region.
- Experience from an international work environment.
- Excellent skills in the English and Swedish language and ideally in at least one other Nordic language.
- Excellent skills in Microsoft Office Suite software
Desirable personal characteristics
To succeed in this role, you should be result-oriented and have strong organizational skills with the ability to lead and prioritize projects within tight time frames. Furthermore, you should have the ability to work both independently and as a team player and have excellent interpersonal and communication skills.
In this recruitment Ipsen collaborate with Scientific Solutions and all questions and applications will be managed by Scientific Solutions.
To apply for this position, send in your CV and a short personal letter by email to firstname.lastname@example.org
Welcome with your application as soon as possible and by the latest on Sep 30 th 2021. We are screening the applications on a running basis.
For further questions, please contact:
Rebecka Rääf Hübinette at Scientific Solutions by phone +46 73 244 21 65 or by email Rebecka.email@example.com
Sara Gustafsson by phone +46 709 73 17 47 or by email firstname.lastname@example.org
Scientific Solutions specialises in talent supply for Life Science companies. We focus on management and specialist roles mainly within R&D, Clinical, Regulatory, Drug Safety, Sales and Marketing. www.scientificsolutions.se