We are currently searching for an experienced regulatory professional in Denmark to manage a team of 11 in one of the bigger pharmaceutical companies in the area.
As a Regulatory Affairs Lead you will support both Denmark and Iceland in leadership of the regulatory group to ensure that submissions are made in a correct way and within the deadlines. The two parts of the job consists of new MA applications and Compliance of regulatory guidelines.
You will be reporting to the Regulatory Lead of Nordic and Baltic countries.
Tasks will include but not be limited to>
· Responsible for keeping the regulatory group updated scientifically and legally within the regulatory area. This includes providing training to internal and external members of the regulatory team.
· Manage the preparation, submission and follow-up of the applications to regulatory authorities both locally and to the EMA.
· Designing and implementing a local ad-hoc action plan
· Keep consistently up to date with the regulatory information and updates the appropriate people
· Works cross functionally with areas such as medical, finance, marketing, external affairs, market access and more to keep to track processes and manage answers to objections from the authorities.
· provide with regulatory guidance to management teams, co-marketing partners, licence companies
· Track changes and updates in the legislation that might affect the company
· MS Degree from university within life science or similar areas
· Past experience of effectively managing a team
· Extensive knowledge of the local and EU regulatory procedures and guidelines
· Fluent communication in both Danish and Swedish
· Experience of Quality and GDP
· Excellent computer knowledge and experience of working with excel, database applications and internet usage as well as working with word- processing and spreadsheets.
We are looking for an individual that can take own initiative and work independently. You need to have good judgement and strong interpersonal skills to manage the team as well as clear and transparent communications and problem solving skills.
To get more information about this role please contact or call me on