Regulatory Affairs Specialist II

• The Regulatory Affairs Specialist is a project manager, (PM) responsible for the RA lifecycle management on Medis dossiers for Teva s 3rd party client business (Medis), ensuring information flow and provision of supportive documents reaches the clients
• The PM is responsible for liaison with Teva s 3rd party client business (Medis) supply chain, Teva site RA and other relevant functions

• 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

• M Pharm/ MSc: 0-1 years of experience in RA
• Good organisation skills
• Good communication and presentation skills
• Good written and verbal knowledge in English
• Strategic thinking and flexibility to adapt to changes
• Good team player
• Good computer skills
• Proactive way of working and able to work independently

Group leader regulatory affairs