job title: Regulatory affairs associate 1 (Teva Pharmaceuticals)

Roles and Responsibilities

How you’ll spend your day

• 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 the 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

Your experience and qualifications

• B Pharm/ M Pharm

• 1 to 4 years relevant experience in RA with EU & International market

Personal Characterisics

• 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