Regulatory Affairs Senior Professional

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 Senior Associate, Global Regulatory Affairs – Innovative Medicines (GRAIM) (Europe) is primarily responsible for supporting the GRAIM teams located in Europe by preparing and managing regulatory documentation, ensuring that regulatory affairs (RA) tools and Teva databases/systems are up-to-date, and for providing administrative support to GRAIM team leaders and support for various pre- and post-approval regulatory activities.

How you’ll spend your day

• Support EURA strategists in the preparation and submission of Clinical Trial Applications (CTAs) and CTA maintenance activities (e.g. Substantial Modifications), including interactions with external stakeholders (e.g. Contract Research Organizations) and redaction of regulatory documentation related to personal and commercially confidential information in collaboration with EURA strategists
• Support EURA strategists in the preparation and submission of regulatory post-approval filings via the centralized, decentralized and mutual recognition procedures, including labelling activities
• Support EURA strategists in liaising with Health Authorities where appropriate
• Understand and accurately follow guidance on all EMA/EC regulations, guidelines, procedures and policies 
• Support of team leaders with departmental reporting and metrics, including maintenance of databases, workplan, and report compilation 
• Provide general filing and administrative support for EURA strategists, such as uploading correspondence with Health Authorities to the eDMS, collecting and checking specific administrative documents for Module 1 of the registration dossier, proof reading of mock-ups for the existing products portfolio against the approved labelling text, and ensuring compliance at all times
• Support EURA strategists in maintaining the electronic documentation management system (eDMS) and regulatory information systems
• Work closely with the line manager to ensure completion of tasks within agreed timelines
• Identify and escalate areas of administrative process improvement
• Actively participate in the establishment, review and improvement of working procedures relevant for GRAIM (Europe)
• Provide ad hoc support to requests from GRAIM team members and other functions
• Support special tasks and/or specific topics on behalf of the EURA team and share knowledge
• Occasional travel might be required

Your experience and qualifications

• Minimum bachelor's degree in a scientific or healthcare discipline, or an equivalent combination of education and related experience; Pharm.D, M.S., Ph.D., or equivalent, or sufficient related experience would be ideal
• Experience in the pharmaceutical industry, ideally in Regulatory Affairs
• Practical experience with European regulatory activities/submission procedures would be preferable
• Experience and knowledge of the eCTD would be ideal; a basic understanding of European regulatory requirements and guidelines would be highly preferable
• Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, Outlook, and Adobe Acrobat; use of databases and eDMSs would be preferred
• Excellent verbal and written communication in English, ability to work under pressure and to tight timelines, effective time and organization management, and initiative
• Creativity, team work, problem solving skills, flexibility, planning and organization skills, attention to details
• Ethical scientific and intellectual integrity

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.