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Regulatory Affairs Manager

Reference:AQWO-662653 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Regulatory Affairs Manager
Our client is an international pharmaceutical discovery organisation and they are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis. The ideal candidate will be a dynamic individual, who is self-driven, organized and capable of working on their own initiative in a start-up environment.

• Coordinate, prepare and be accountable for all regulatory affairs related activities such as clinical trial applications, organization and preparation of regulatory advice meetings and compilation of IMPDs and comparable documents
• Provide the cross-functional team with regulatory input in order to obtain timely approvals and contribute to the product development strategy planning
• Oversee internal activities and external vendors to ensure compliance with all regulatory requirements

• Life Science degree and a minimum of 5 years EU/US Regulatory Affairs experience in a pharmaceutical company/ CRO
• 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
• Must have excellent oral and written communication and presentation skills
• International and domestic travel may be required

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252