Job Responsibilities:
• You will be responsible for the collection and presentation of product registration data to ensure timely registration of new products, new indications and the renewals of established products.
• You will provide regulatory input to the therapeutic project teams located at product development sites for projects to which you will be assigned, monitor the activities of development towards new MAA's and new indications to ensure they meet European registration requirements and troubleshoot or resolve any problem on the critical path to product registration or renewal.
• You will interact with European subsidiary regulatory managers in the execution of regulatory strategies and drug registration activities to ensure the earliest possible product license approvals.
• You assist subsidiary personnel by providing scientific support, when necessary, permitting them to be more effective in negotiations with their respective agencies.
• You maintain a sound scientific knowledge and expertise for all assigned products as well as on the European regulatory requirements and environment.
• You will identify and track changes/trends in the medical practice and attitudes within European countries that might impact product and project responsibilities.
Experience profile:
• You have a bachelor's or a Master's degree and 3-5 years experience in regulatory affairs People with a Ph.D. in a biological science, chemistry or related field plus some initial experience in regulatory affairs will also be taken into consideration.
• We are looking for someone with excellent communication skills in English, both oral and written. |