Regulatory Affairs

Job description Lifecycle management on specific products for Europe and international market Responsible at all times that regulatory modules under Product Manager responsibility are up to date, in accordance with agreed procedure as applicable Inform, prepare and submit variations either directly to authorities or to Teva s 3rd party client business (Medis) Follow up on variation submissions, timelines and approvals, in accordance with agreed procedure as applicable Compile answers to any deficiency questions from authorities or clients Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure as applicable Regular status updates to management Goal setting and follow up together with his/her supervisor Professional communications with both internal and external stakeholders Work on other specialised projects as defined by managers of RA