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The Regulatory Affairs and Drug Safety departments are responsible for upholding and implementing ethical, legal and global standards. Their spectrum of responsibilities covers everything from submitting dossiers for new drugs to constant monitoring of our medical products all the way to communicating with the appropriate authorities.
Drug safety (also known as pharmacovigilance) encompasses the continuous monitoring of our medical products and medicines after market launch, with the aim of providing important safety information, complying with ethical standards, and meeting quality targets. This includes compiling potential drug risks, communicating with responsible authorities, and continuous monitoring of the safety of medicines, enteral nutrition, and medical products in accordance with national and international requirements.
Degree in medicine or science as well as medical and science writing skills and the ability to coordinate and collect information from internal and external sources.
Regulatory Affairs safeguards product and patient safety as well as general compliance with applicable regulations. This department is responsible for areas such as strategic planning as well as the submission and monitoring of applications for new drug approvals.
It maintains contacts with the responsible authorities, monitors compliance with legal regulations, e.g. by ensuring that marketing materials conform with Germany’s Health Services and Products Advertising Act (Heilmittelwerbegesetz – HWG), and provides internal information on new developments and legislative changes to everyone involved.
Degree in a medical, scientific, or technical field.