job title: Regulatory affairs associate 1(teva)

Roles and Responsibilities

How you’ll spend your day

1. Editorial Tasks

   • Perform various editorial tasks.

   • Review of SmPC and PIL as well as packaging materials using a review protocol.

   • Adapt texts to the current QRD template.

   • Proofread texts.

   • Prompt provision of product information and comments in regulatory database (GRIDS).

   • Responsibilities under the role of super-editor (GRIDS).

   • Coordinate and handle inquiries from other departments, locations, and service providers.

2. Screening for innovations in the EU regulatory environment

   • Monitoring of the literature (guidelines, best-practices) in the regulatory affairs environment for innovations, especially in the area of central approvals.

3. Translation Management for EU Centralized Procedures

   • Planning of all process steps after receiving the translation request.

   • Coordinate translations of English product information into the languages of EU member states, including Norway and Iceland, for CPs.

   • Internal QC check: coordination of communication between all stakeholders (local Markets, translation agency).

   • Coordinate linguistic reviews.

   • Evaluate translation tables from translation agency and/or local markets.

   • Providing necessary documents for submission (e. g. WORD annotated, PDF clean, translation tables).

4. SAP

   • Cost Center Administrator (release of invoices, accounting).

5. ARIBA

   • Management of purchase requisitions within the framework of service contracts (e.g. translations).

      6.Work in a team environment.

7. Perform all other job-related duties as required by management and dictated by process changes.

Your experience and qualifications

• Experience: Experience in Regulatory Affairs or basic knowledge of European pharmaceutical law and the regulatory affairs environment.

• Qualification: Completed training as a pharmaceutical-technical assistant or medical assistant.

• Other: Intermediate to advanced English skills (spoken and written), excellent MS Office skills, basic knowledge of European pharmaceutical law and regulatory affairs, project management experience.