The Regulatory Department deals with submissions of registration applications for new drugs, renewals of existing licenses, and any variations to the existing licenses. All regulatory issues must be handled according to the laws and regulations of the health authorities in the relevant country where the product will be marketed (Israel, Europe, US, and the rest of the world).
Regulatory Project Managers are required to understand the pharmaceutical and the clinical aspects of the drug, along with the legal requirements for submission. Preparing a regulatory dossier for submission includes defining the required information, examining this information and designing it to meet the requirements of the country where the dossier will be submitted. The Project Manager is in constant contact with all relevant departments within the company, as well as the health authorities in Israel and internationally. Regulatory Project Manager is a challenging position which requires professionalism and responsibility.
The Regulatory Department is a pivotal center of information and decision-making which affects the company both internally and the company's relationship with external authorities.