Expiry Date: 12-07-2021
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory Affairs Senior Manager for Immunology products, Based in Brussels
Dynamic and exciting Regulatory Affairs Senior manager role, covering Immunology development projects. Based in Brussels, supporting clinical and non-clinical activities for all phases of development.
Location: Central Brussels, Belgium
My client organisation is a rapidly expanding medium sized Bio/Pharmaceutical company with an excellent pipeline with a mixture of both NCE’s and NBE’s in all stages of development. The regulatory department covers Europe, Middle-East and Africa and you will be based at the EU corporate Headquarters, which is the hub of all strategic decision making.
Despite the current EU economic climate, this client is still a growing company. The organization is always exploring, expanding, and adapting to changes and it recognizes excellent performance with promotions and development opportunities internationally, whenever appropriate.
From the EU HQ you will have a friendly and dynamic working environment in state of the art offices that have a number of staff restaurants, offers flexible working hours, dedicated parking, is in close proximity to the train, bus and metro stations, offers good options to work from home, and provides all employees with a highly rated benefits package including comprehensive medical and healthcare insurance for you and your family, as well as lunch vouchers and travel vouchers. A fully comprehensive re-location package (including accommodation and bonus/allowances) is also available if needed.
As a Regulatory Affairs Senior Manager you will be responsible for providing specific regulatory affairs leadership and support for a new brand / portfolio of 6 Biological indications in Phases 2 and 3 of development operating as the EU Regulatory Liaison in a supportive EU Regulatory Affairs team focused on strategy development & delivery of successful registrations.
This regulatory department really is a great place to work with good individuals and a great management team that will bring the best out of you. You will be encouraged to strive for continual improvement and development of your technical and managerial expertise whilst working with high value / potential blockbuster indications. This role comes with fantastic promotion prospects to either AD level or GRL and a real career development plan.
You will need to have at least 5-10 years Regulatory affairs experience in development or MAA activities for EU or International regions and worked in Phase 1 to Phase 3 clinical studies or have experience in Orphan drug disease supporting a variety of related submissions i.e. Orphan drug designation (US, EU), knowledge of paediatric study requirements in either the EU or US or supported HA/Scientific advice meetings.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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