Job Description

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.

We would like to invite applications for the role of Regulatory Affairs Associate at our Harlow office to support European Generic new submissions via decentralised and mutual recognition procedures, typically for solid oral dosage forms, solutions and/or suspensions.

Are you ready for the challenge of working in Teva\'s EU Regulatory Affairs department? If so, please continue reading!!

Do you know that our Harlow office is a Centre of Excellence (CoE) for Regulatory Affairs within Teva, with teams covering both European and global licensing for medicines and over-the-counter (OTC) products? The site is conveniently located half an hour commute from central London. To learn more about Teva UK, follow this link:

A Day in the Life of a Regulatory Affairs Associate III...

On a daily basis, with support from your line manager, you will be working cross-functionally with R&D colleagues to:

• Ensure dossier technical content is optimal and aligned with EU Regulatory data requirements for new EU Marketing Authorisation Applications and post approval variations, where required
• Perform the necessary regulatory activities for your assigned projects from pre-submission until post-approval handover to regulatory maintenance teams. This includes review and optimisation of dossier content (particularly Module 3), compilation and submission of files, resolution of Health Authority questions in cooperation with other functions, and submission of variations where required
• Ensure that files and responses are submitted and approved on time
• Communicate regulatory information for assigned projects before, during and after approval and provide regulatory support to project teams, stakeholders and customers, as required
• Track and monitor queries/deficiency letters/commitments from/to European Health Authorities to ensure these are implemented and conformed to in a timely manner
• Ensure that all activities fully comply with departmental and company SOPs and that all internal tracking tools and databases are maintained, accurate and complete

Through training and on the job experience you will develop and grow your understanding of the European regulatory environment and supporting data requirements.

Who we are looking for

Do you have...?

• Pharmacy/Chemistry or Life Sciences degree
• Regulatory Affairs experience working with medicines (a must)
• Knowledge of:

• Pharmaceutical & scientific processes
• Regulatory requirements, process, procedures, & pathways
• Submission and registrations, particularly decentralised or mutual recognition procedures
• Internal/external communications skills (written & oral) and collaboration skills (local/regional)
• Good attention to detail and time management skills

Are you...?

• Able to work within a team and with independence on all routine activities
• Self-motivating
• Open to change
• Analytical

Enjoy a more rewarding choice

• Enjoying time with your families (25 days of annual leave, Hybrid approach to home working, Pension scheme)
• Looking after your health (Life & Critical Illness Insurance, Private health insurance, Sports and Health Programme - including health days and nutritional counselling, On-site Canteen)
• Recognizing your value (Recognition programs to reward our employees with our company bonus scheme)
• Boosting your potential (Virtual Learning Centre)
• Well-being and D&I focused company

Reports To

Ass Dir/Dir Regulatory Affairs

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:

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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.#TJ

Teva Pharmaceuticals