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 (in conjunction with line manager) oversee all regulatory activities for assigned projects including compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.

Are you ready for the challenge of working in Teva’s UK&IE Regulatory Affairs department? If so, please continue reading!!

Do you know that our Harlow office is the 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: https://www.tevauk.com/careers/explore-our-uk-sites/

A day in the life of a RA Associate...

• You will perform the necessary regulatory tasks – i.e. dossier compilation, data and documentation review, submission execution - to obtain new Marketing Authorisations in UK (GB/NI) for both generic and innovative medicines (with an small exposure to our OTC business as well).
• You will prepare, compile, review and submit appropriate high quality post-approval changes (variations, renewals, PIQU submissions) and responses to Health Authority questions in accordance with Departmental and Company SOPs, Work Instructions and current legislation.
• You will work closely with EU RA Competence Centres in order to provide timely UK/IE specific documentation and/or information in support of EU new submissions and/or variations and renewals.
• You will ensure approvals are secured within the stipulated timelines for designated projects.
• You will maintain registration documentation and associated electronic databases, in line with in-house procedures.
• You will provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
• You will develop and maintain a thorough and up-to-date understanding of the UK (GB/NI) and IE regulatory environment and supporting data requirements.
• You will work closely with line manager to identify, evaluate and communicate clearly all perceived and evolving regulatory risks to project and business teams.
• You will prioritise, plan and monitor allocated projects against defined timelines.
• You will maintain and develop awareness of current/pending regulatory legislation and guidelines
• You will identify and initiate areas for process improvement, and manage changes as required
• You will follow regulatory guidance and Teva procedures to ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment.

Who we are looking for

Do you have...?

• Degree in life sciences/pharmacy or equivalent qualification(s)
• Experience in the Pharmaceutical Industry within Regulatory Affairs
• UK, IE or other EU member state experience and knowledge of regulatory procedures
• Basic understanding of processes and departments within a pharmaceutical company

Are you...?

• Excellent oral and written communicator
• Able to work under pressure and to tight time deadlines
• Able to work under own initiative
• Analytical thinker (data rational)
• Computer literate
• Flexible

Enjoy a more rewarding choice

• Enjoying time with your families (25 days of annual leave, 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

Manager/Senior Manager Regulatory Affairs

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