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Regulatory Affairs Associate - EU - Generics + OTC

Date: Nov 22, 2022

Location: Harlow, GB, CM20 2FB

Company: Teva Pharmaceuticals

Who are we?

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 support European new submissions, typically for solid oral dosage forms, solutions and/or suspensions & OTC.

 

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 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….

  • You will work closely with your line manager and R&D or third party partners to ensure that technical file content is optimal and aligned with EU Regulatory data requirements
  • You will (with support from line manager) oversee all regulatory activities for assigned projects until handover to regulatory maintenance teams including dossier risk assessments, compilation and submission of files, resolution of Health Authority questions in cooperation with other functions, and submission of variations where requested.
  • You will work with your line manager to ensure that files are submitted and approved on time, optimising file content and working with other functions.
  • You will communicate regulatory information for assigned projects before, during and after approval and the maintenance work on post-approval variations for authorised products until the project is handed over to regulatory maintenance teams.
  • You will (with support from line manager) perform the necessary regulatory tasks – i.e. dossier compilation, data and documentation review, submission execution, file quality rating etc - to obtain new Marketing Authorisations and Extension Applications in the EU.
  • You will track and monitor queries/deficiency letters/commitments from/to European Health Authorities to ensure these are implemented and conformed to in a timely manner.
  • You will develop an understanding of the European regulatory environment and supporting data requirements.
  • You will (with support from line manager) provide regulatory support to project teams, stakeholders and customers, as required.
  • You will ensure that all activities fully comply with departmental and company SOPs and that all internal tracking tools and databases are maintained, accurate and complete.

Who we are looking for

Do you have...?

  • Pharmacy/Chemistry or Life Sciences degree.
  • Regulatory Affairs experience working with medicines (essential)
  • Knowledge of:
    • Pharmaceutical & scientific processes
    • Regulatory requirements, process, procedures, & pathways
    • Submission and registrations
  • Internal/external communications skills (written & oral) and collaboration (local/regional)

 

Are you...?

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

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

Function

Regulatory Affairs

Reports To

Assoc Dir 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