Regulatory Affairs Associate - UK&IE

Location

United Kingdom | United States

Job description

Who we are

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.

We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

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!!

To learn more about Teva UK, follow this link:

A Day in the Life of….

• 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 products.
• 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

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Who we are looking for

Do you have...?

• Degree in life sciences/pharmacy or equivalent qualification(s) or experience.
• UK, IE or other EU member state proven regulatory affairs experience with medicines .
• Understanding of processes and departments within a pharmaceutical company
• Effective time and organisation management 

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
• Computer literate
• Flexible

What Teva can offer you

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

Manager 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: 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, colour, 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. #TJ

Job tags

Salary