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Manager/Senior Manager - Regulatory Affairs - Innovative Medicines, Europe
Date: Sep 26, 2024
Location:
Harlow, United Kingdom, CM20 2FB
Job Id: 58490
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of innovative&generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
We are recruiting for a 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 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 feed-back or decisions from European Competent Authorities during 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 to 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 a 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 consider 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)
* Well-being and D&I focused company
Function
Regulatory Affairs
Medical Regulatory Affairs
Reports To
Associate Director, EU Regulatory Affairs Innovative Medicines
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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. #TJ
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