The company

Eisai is a global leading research-based pharmaceutical company driven by “giving first thought to patients and their families and increasing the benefits that health care provides”. Eisai is committed to research and development and has an exciting pipeline from new discoveries, acquired molecules and further development of licensed products within Neurology, Gastroenterology, Critical Care and Oncology. With operations in U.S., Asia, Europe and the domestic market of Japan, Eisai employs 11.000 people worldwide. The Nordic headquarter is in Sweden, Danderyd, north of Stockholm.
Further information about the company in Europe can be found on http://www.eisai.co.uk.

The Nordic Organisation
The Nordic team consist of 29 people in total in sales, marketing, medical and finance and is expected to grow over the coming years. The Nordic organisation has a clear focus on two therapy areas – Oncology and Neurology (epilepsy). The medical team is led by the Medical Director and consists of a Medical Manager Oncology Nordics, a Medical Manager Neurology Nordics, three Medical Scientific Liaisons (two in Oncology and one in Neurology), one Regulatory Affairs Manager, One Quality Assurance Manager and a Market Access Manager.

 

Regulatory Affairs Manager Nordics, Eisai

Opportunity in Eisai, a growing specialty pharma company with an innovative product portfolio and an attractive company culture

The position – Regulatory Affairs Manager Nordics

Job title: Regulatory Affairs Manager Nordics, Eisai Nordics
Employment Type: Full-time
Department: Global V & A
Report to position: Medical Director Nordics
Location: Eisai Nordic Headquarters, Danderyd, Stockholm, Sweden

Main purpose of the job

• Responsible for Regulatory Affairs in the Nordic region. Be specialist and main contact point internally and externally for Regulatory Affairs activities for the Company´s products in the Nordic countries
• Responsible for Pharmacovigilance and act as the Local Safety Officer for the Nordic region. Be specialist and main contact point internally and externally for Pharmacovigilance activities and projects
• Responsible for Medical Information and ensure compliance with company policies, procedures and standards. Be a specialist and be the main point of contact internally and externally for Medical information activities and projects.
• Maintain current knowledge of regulations, legislations, guidelines and requirements in the field of Quality Assurance, Pharmacovigilance and Regulatory Affairs. Communicate relevant changes to functions concerned in order to ensure compliance and that most appropriate strategy is taken.

The position reports to the Medical Director Nordics.

Experience and qualifications required
• M. Sc. Pharmacy or similar Life Science qualification
• At least 3 years of experience from Regulatory Affairs
• Previous experience working with Pharmacovigilance is preferred
• Experience of project management

Required skills and competencies:
• Ability to successfully prioritise, work on multiple tasks and meet strict deadlines
• Highly organized with a strong eye for details
• Flexibility, adaptability, pro-activity and works well under pressure
• Possess a strong sense of responsibility and have a good track record of working independently
• Eye for detail. Able to do the “head’s down” work in addition to the other requirements
• A strong willingness to learn and develop new skills
• Good communication skills
• Team player
• Experience of using Microsoft Office

Language skills:
Fluent in Swedish and English. Good understanding and ability to communicate in the other Nordic countries.

Opportunities with the role
Eisai is a growing company worldwide and in the Nordic and European region. In the expansion and development of the company, Eisai maintains full focus on the hhc philosophy (human health care), which means a full commitment to deliver health to patients and their families. This is reflected in the spirit and the positive culture that you find among Eisai employees. Eisai encourages employees to engage and spend time with patients to be able to truly understand patients’ situations and simply do good for patients.
Eisai is a dynamic company with short decision lines and a broad-based responsibility for every individual employee. That means an opportunity to influence and take initiatives that will add value to patients, healthcare and the society.

Eisai has a solid platform for Regulatory affairs in the Nordic. The product portfolio and pipeline are innovative and there will be several important launches the coming years.

The Regulatory affairs Manager role is a broad-based role in close collaboration with internal and externa collaborating partners. The role will be a key member for the future development and success of the Eisai business in the Nordics.

The right candidate will be part of an experienced and professional team with a great spirit. The Regulatory affairs Manager will receive support and development from the Nordic management and Regulatory affairs EisaiEMEA.

Eisai offers continues development for all personnel, both individual and team oriented. An individual development plan will be agreed with the line manager.

Contact
For inquires and more information about the position, please contact Magnus Klingberg Sr Recruitment Consultant at PeakSearch. Apply for the position at http://www.peaksearch.se.

Contact details
magnus.klingberg@peaksearch.se mob: +46 (0)70-678 09 92, tel: +46 8 545 00 100