Regulatory Affairs Executive
|Job Title:||Regulatory Affairs Executive|
|Contact Name:||Laurentina Kennedy|
|Job Published:||10 months ago|
Our client has it headquartered in Dublin, Ireland, is a privately held, clinical stage, pharmaceutical drug discovery, and development company. They are recruiting for a Regulatory Affairs Executive
Regulatory Affairs Executive will coordinate, prepare and be accountable for all regulatory affairs related activities such as clinical trial applications, organisation and preparation of regulatory advice meetings and compilation of IMPDs and comparable documents.
The Regulatory Executive will provide the cross-functional team with regulatory input in order to obtain timely approvals and contribute to the product development strategic planning.
They will oversee internal activities and external vendors to ensure compliance with all regulatory requirements.
Bachelor's Degree in Science.
You will have a relevant Life Science degree and a minimum of 5 years EU/US Regulatory Affairs experience in a pharmaceutical company.
Thorough understanding of the clinical trial application process in the US and Europe
Exposure to the NDA and MAA submission process
Experience dealing with regulatory authorities in relation to investigational medicinal products is a requirement.
International and domestic travel may be required.
For further information on this Regulatory Affairs Executive position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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