Regulatory Affairs Associate, EU Labelling

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Regulatory Affairs (RA) Associate, EU Labelling, Global Regulatory Affairs – Innovative Medicines (GRAIM) Europe is primarily responsible for supporting GRAIM teams located in Europe to develop and maintain English EU Product Information (PI) documents for innovative products, plays a key supporting role in ensuring that PI documents are accurate, compliant and aligned with EU regulatory requirements and manages translations of PI documents for Centralised Procedures.

How you’ll spend your day

• Assist in drafting, reviewing and updating English EU labelling / PI documents including the Summary of Product Characteristics (SmPC), Labelling, Package Leaflet (PL) and packaging components including active participation in cross-functional team discussions.
• Upload and maintain labeling documentation within Teva’s electronic documentation management system (eDMS).
• Support the submission of labelling documents within EU procedures, for example by providing submission ready labelling documents.

• Support the creation of responses to authority queries relating to labelling documents.
• Ensure compliance of labelling documents with EU regulatory requirements / guidelines, QRD templates and internal standards.
• Support the determination of an implementation plan and tracking of the implementation of updates due to new requirements (e.g. new excipients warnings, QRD template update).
• Coordinate translations of English PI documents into all EU languages for Centralised Procedures including being the primary contact for external translation companies; coordinate Linguistic Reviews and internal QC checks.

Your experience and qualifications

• University degree in natural sciences or healthcare discipline (e.g., Pharmacy, Biology, Human Biology, Medicine).
• Ideally some experience in the pharmaceutical industry with knowledge of EU regulatory and labelling requirements.
• Excellent verbal and written communication in English, ability to work under pressure and to tight timelines, effective time and organization management and initiative.
• Creativity, ability to work as a team as well as independently, problem solving and analysis, flexibility, planning and organization, attention to details.

• Basic understanding of processes and departments within a pharmaceutical company; Microsoft Word, Excel, PowerPoint, Sharepoint and Outlook, Adobe Acrobat; Use of databases and eDMSs would be preferred.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:  Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.