Teva Regulatory Affairs Associate - UK & IE 

United Kingdom, England 

515520982

We would like to invite applications for the role ofto (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.

• You will (with support from Line Manager) prepare, compile, review and submit appropriate high quality post-approval changes (variations, renewals, PIQU submissions) and responses to Health Authority questions in accordance with in-house standards and current legislation.
• You will provide administrative support for new Marketing Authorisation Applications for UK (GB/NI)
• You will provide national support for EU variations / new marketing applications in line with deadlines set by the requestor and in accordance with in-house standards and current legislation.
• You will ensure approvals are secured within the stipulated timelines for designated products and projects.
• You will maintain registration documentation and associated electronic databases, in line with Teva’s processes and procedures as outlined in the relevant SOP’s and WI’s.
• You will provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
• You will work closely with Line Manager to prioritise, plan and monitor allocated projects against defined timelines.
• You wil maintain and develop awareness of current/pending regulatory legislation and guidelines
• You will provide general support activities for the UK/IERA team including support for Teva’s finance system (raising PO’s and approving invoices)

Do you have...?

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

• 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

Manager Regulatory Affairs

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