Description
Responsibilities:* Working alongside the Senior Regulatory Affairs Manager, you will be involved in the preparation, maintenance and management of clinical trial applications for submission to regulatory authorities in Ireland and worldwide.
* Liaising with Health Authorities and leading Health Authority interactions as required.
* Provide guidance for the data necessary for Marketing Authorisation Applications (MAAs), Clinical Trial Authorisations (CTAs), Investigational New Drug (IND) dossiers and New Drug Applications (NDAs).
* Overseeing clinical submissions to Health Authorities.
* Maintaining cGxP and H&S knowledge applicable to the job.
* Liaising with the Pharmacovigilance team in ensuring safety-related documentation is maintained.
Requirements:
* A good degree in a Life Sciences - related subject.
* Minimum 4 years Regulatory Affairs experience and preferably experience of compiling and managing clinical trial submissions as well as sound GCP knowledge.
* A proven track record of managing clinical trial submissions in the EU and preferably other countries Worldwide.
* Experience of the US IND process is highly desirable