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. The Group has about 5,800 employees 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 45 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 ultra-rare bone disorders. We also have our Baltic marketing organization, with around 20 people, belonging to the cluster.
The Regulatory Affairs department in the Nordic and Baltic Cluster has currently 5 employees and is expanding to 7. 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 achieving new registrations efficiently and as quickly as possible. You will maintain and optimize existing registrations for all assigned Ipsen products and you should have in depth knowledge of national regulatory 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 new registration activities in the Nordic countries in compliance with registration plans set up with the local Leadership Team and Ipsen Global Regulatory Affairs.
- Responsible for the appropriate regulatory life cycle management of assigned products, including all regulatory variations as well as appropriate implementation of the changes to products communicated within Ipsen.
- Responsible for keeping the labelling material for assigned products updated and in line with regulatory requirements in the Nordic countries.
- Responsible for timely review and updates to the relevant Physicians’ Desk Reference 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 from the Nordic region into the TRACKWISE database.
- Back up for the local Pharmacovigilance Manager.
- 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
Apply no later than Feb 7th 2020.
For further questions, please contact Sara Gustafsson at Scientific Solutions by phone +46 709 73 17 47 or by email email@example.com
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