Manager or Senior Manager - Regulatory Affairs
to work within the Global Regulatory Affairs – Innovative Medicines (Europe) team. You will be working with key
Innovative products
as part of Teva's Pivot to Growth strategy. 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.
We have a hybrid approach to home working! A day in the life of a Manager/Senior Manager Regulatory Affairs... You will develop regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities. Depending on your experience, you may also have the opportunity to do this on a Global scale in the capacity of Global Regulatory Lead. You will obtain regulatory approvals and other feedback or decisions from European Competent Authorities during the development of innovative medicinal products. You will support Clinical Trial Applications under the new Clinical Trials Regulation. You will obtain registrations for innovative medicinal products in the EU and ensure that the registrations for existing marketed products are maintained. You will provide regulatory guidance to cross-functional teams within Teva. Your experience and qualifications Do you have? A strong scientific background with a BSc degree in Life or Pharmaceutical/Healthcare Sciences – ideally with an MSc or PhD. Substantial European regulatory affairs experience (must have). Experience in Clinical Trial Applications in the EU (must have). Innovative Medicine experience
in Immunology and/or Oncology and/or Gastroenterology and/or Respiratory
therapeutic areas is a significant advantage, but we are open to considering any therapeutic area. Experience with Medical Devices and the Medical Device Regulation would also be an advantage. Strong leadership and interpersonal skills. Are you? An excellent written and verbal communicator and confident presenting/communicating with local and global groups. Able to work under pressure to meet tight deadlines. A strategic thinker with strong problem-solving skills. Enjoy a more rewarding choice Enjoying time with your families (25 days of annual leave, hybrid approach to home working, pension scheme, car or car allowance). Looking after your health (Life & Critical Illness Insurance, private health insurance for you and your family, 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 Sub Function Medical Regulatory Affairs Reports To Associate Director, EU Regulatory Affairs Innovative Medicines 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, 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. 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.
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