Do you have experience with Regulatory Affairs and are you keen on a Nordic position?
On behalf of a pharmaceutical company situated in Hørsholm north of Copenhagen, Forum Consult is looking for a highly skilled Regulatory Affairs Professional.
About the department
The regulatory affairs department is a very efficient team taking care of registration of the company group’s products in the Nordic countries. We are searching for a new colleague to help us managing an increasing number of marketing authorizations. The position is reporting to the Nordic Regulatory Affairs Manager.
To assist the European Regulatory Affairs department with preparation and submission of new marketing authorization applications and life cycle activities (i.e. variations etc.) for CP/DCP/MRP products
To manage life cycle activities for nationally approved products
To coordinate translation of product information (SmPC, PL and labeling)
To coordinate preparation and update of packaging material
To participate in introduction of new products and implementation of changes with effect on the packaging material
To drive the preparation and updating of working instructions related to the regulatory processes
University degree in science, pharmacist or equal
Previous regulatory experience
Quality and service minded
Detail-oriented and at the same time able to embrace the broad perspective
Ability to manage multiple tasks and complete them within the given deadline
Good collaboration skills
Excellent written and verbal communication skills in Danish and English.
Experience with the other Scandinavian languages
Your personal profile
A highly professional sparring partner to other colleagues and health authorities in the Nordic countries
A strong communicator who thrives to work in an international environment with contact to people from different countries and functions within the company group
A team player who is also able to work independently
Have a clear focus on agreed objectives and priorities
A challenging job in an international organization with a competitive salary incl. pension scheme and health insurance and excellent possibilities for personal and professional development.
Forum Consult is looking forward to receiving your application incl. CV by e-mail: email@example.com. The deadline is 30. oktober 2012 but please send your application as soon as possible as review of applications and interviews will be conducted on an on-going basis. Your application will be handled confidentially.
For further information, please contact Anne Mette Svensson at Forum Consult, tel. +45 60604748.