Teva Regulatory Affairs Associate - EU Generics 

United Kingdom, England 

996876538

We would like to invite applications for the role ofRegulatory Affairs Associateat our Harlow office to supportEuropean Genericnew submissions via decentralised and mutual recognition procedures, typically for solid oral dosage forms, solutions and/or suspensions.

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.

• Pharmacy/Chemistry or Life Sciences degree
• Regulatory Affairs experience ideally with medicines. We are also happy to consider candidates coming with R&D and/or Formulation background.
• Knowledge of:
  • Pharmaceutical & scientific processes
  • Regulatory requirements, process, procedures, & pathways
• Internal/external communications skills (written & oral) and collaboration skills (local/regional)
• Good attention to detail and time management skills
  

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

• 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.
  

Dir Regulatory Affairs

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.