Regulatory Affairs Associate - EU - Neuroscience

Regulatory Affairs Associate - EU - Neuroscience Date: Apr 13, 2023 Location: Harlow, United Kingdom, CM20 2FB Company: Teva Pharmaceuticals Job Id: 45189 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.

Teva is recruiting a Regulatory Affairs Associate to work within the Global Regulatory Affairs – Innovative Medicines (Europe) team, specialising in the Therapeutic Area (TA) Neuroscience, based in our office in Harlow, Essex.

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/

Do you have experience within European Regulatory Affairs? Do you have some experience with pre-approval Regulatory activities and clinical development? We’re looking for someone like you…

A Day in the Life of a Regulatory Affairs Associate...

• You will work within Global Regulatory Affairs team, obtaining registrations for innovative products in Europe and ensuring that the registrations for existing marketed products are maintained.
• You will be responsible for supporting key pre- and post-approval Regulatory activities performed by the TA Neuroscience team. The position focuses primarily on innovative Neuroscience products, though there could be opportunities to support also activities for the Immunology TA in the future.
• You will support and manage the preparation and submission of both centralised and/or decentralised Regulatory pre- and post-approval filings for Teva’s innovative Neuroscience products in Europe
• You will coordinate regulatory aspects in connection with Teva’s Clinical Trial Applications (CTAs) in Europe
• You will co-ordinate Scientific Advices, Paediatric Investigation Plan (PIP) procedures and other pre-approval regulatory activities with the EMA and/or national competent authorities as applicable
• You will participate in the development of RA strategies for assigned products
• You will support the development and/or subsequent maintenance of product labelling
• You will ensure that regulatory obligations for marketing authorisations are met and provide a point of contact for the EMA or national competent authorities
• You will collaborate with internal and external teams, provide European regulatory advice to Teva GRA, General Management, other departments (e.g. Commercial, Medical, Clinical etc.) and project teams
• You will understand, and accurately follow guidance on all EMA/EC regulations, guidelines, procedures and policies and provide feedback to cross-functional teams as needed

Who we are looking for

Do you have...?

• Experience working in European Regulatory Affairs (must have)
• Experience in clinical development and pre-approval Regulatory activities (highly preferred)
• A BSc degree in life sciences, ideally with an MSc or PhD
• Good understanding of European regulatory requirements and guidelines
• Experience and knowledge of the eCTD

Are you...?

• Excellent written and verbal communicator
• Able to work under pressure to meet tight deadlines
  

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

Senior Director 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.