Do you have at least a Bachelor’s degree and proven experience in the industry and a proven experience in Regulatory Operations or closely associated with health authority regulations? Then we have an interesting job opportunity for you!
The primary purpose of this position is to coordinate various activities related to the collection, organization and dissemination of regulatory submissions. The primary focus of the role is on planning and tracking regulatory submissions globally, in this position Europe. You will plan and track maintenance submissions and help define and report on related KPIs such as submission timeline compliance by Affiliates and Clinical Trial Data Disclosure obligations.
In this position you will organize and coordinate information exchange among Regulatory Affairs functions as well as stakeholder groups. You will address complex and divers challenges with decision-making that impacts multiple projects, functional and therapeutic areas. Also you will identify changing regulatory guidance and anticipate impact on submission preparation and processing or other information management activities.
Please note that you do not compose the regulatory files. Your responsibility is to document these and make sure all data is put into the relevant systems.
The type of person we are looking for is proactive, works well under pressure, is fast-paced and also an effective communicator.
Minimum a Bachelor’s degree;
At least two or three years experience with the European Regulatory Guidelines;
Proven previous industry experience; in Regulatory Operations or in a role closely associated with interpretation of health authority regulations, product change control, labeling, submission publishing, or registration tracking;
Speaks fluent English;
Able to communicate with different affiliates en coordinate regulatory processes;
Strong organizational skills and strong decision-making and problem-solving skills;
Available on short notice.
The company is one of the top 20 pharmaceutical companies in the world.