Regulatory Affairs Associate I

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

• Support EU Generics Labeling Managers and Labeling Germany Managers in providing pharmaceutically and medically accurate product labelling, especially for multiple regulatory procedures of one INN.
• Manage translations for Centralized Procedures (CPs).
  
  

How You’ll Spend Your Day

• 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.
• 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.
• 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).
• SAP
• Cost Center Administrator (release of invoices, accounting).
• ARIBA
• Management of purchase requisitions within the framework of service contracts (e.g. translations).
• Work in a team environment.
• 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.
  
  

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas 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.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

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