Expiry Date: 07-02-2023
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
About the client and the role:
Our client is one of the top R&D based pharmaceutical companies, with a solid track record of successes under their umbrella and a wide and diverse pipeline that includes CAR-Ts, mAbs, NCEs and ADCs in multiple therapeutic areas such as Immunology, cardiovascular, hematology and oncology. The company has several high value brands on these therapy areas as well as 6 NMEs in early to half late phase development. We have vacancies in each therapy areas!
They are looking for an individual who is already a Director or very close to it and wants to work at the project/products level with Global Strategy and Regulatory Leadership and a member of the core development team. You will define global regulatory strategies and serve as the RA sub team lead for major submissions, including NDA/BLA/MAA for first submissions and the first round of new indications.
As the EU regulatory expert, you will execute negotiations with the EMA and provide strategic direction and supervision to other regulatory agencies for your assigned projects. You will also represent the Global Regulatory Sciences teams in EU countries including through direction of European Regulatory Teams and be the designated EU Regulatory Liaison.
Our client offers a hybrid working model where you will only attend to the office 50% of the time and their site is located in Uxbridge area.
Degree / Experience Requirements:
Bachelor’s Degree required; advanced scientific degree preferred (Master’s, PhD, PharmD, BSN, etc.) with experience of leading either EU or US & EU regulatory strategies.
Package and Relocation:
My client will buyout your losses including bonus and stock and they will provide you with a yearly stock plan which includes RSUs and Share Options. The role comes with a very good basic salary, car or car allowance, bonus and a full relocation package to cover all your expenses including disturbance allowances and logistics support.
To apply for this role, please contact me Javier Monfort on +44 207 801 3385 or my colleague Ivan Nash on +44 207 801 3388 or press the red “Apply for position” button or send us an email to email@example.com and we will reply by return. We will support you throughout the interview and on-boarding experience.
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