Description
Regulatory Affairs Officer:A leading global pharmaceutical company based in West Dublin is looking to hire a number of Regulatory Submissions Officers to join their global regulatory submissions team in their Dublin office which is their European Headquarters.
Why this company:
You will gain experience doing submissions for multiple European countries, America and Canada. You will also get to work with eCTD while also getting the opportunity to get trained in other areas of regulatory affairs.
Working for this company will give you the opportunity to be involved in different areas, get involved with different functions and to really get to give your input
There are huge learning and development opportunities. There is a real sense of achievement as this company rapidly expands and works through their ambitious expansion and growth plans. The company invests in their staff in terms of training and development and there are strong career opportunities to progress.
The role will involve:
-Ensure timely preparation and compilation of registration dossier for assigned projects in accordance to EU standards and corporate requirements;
-Manage international regulatory submissions according to company strategy and ensure meeting registration deadlines, via timely answering Health Authorities' queries and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, in order to support the timely introduction of new product into markets;
-Maintain assigned products' Marketing Authorisations via timely variations and renewals submissions and their approvals;
-Build departmental awareness of local regulatory requirements in global markets;
-Compile regulatory component of annual product review and PSUR;
-Archive the registration documentation acc. to internal standards; introduce and regular up-dates to the internal RA database;
-Perform assigned tasks with the highest quality and in accordance to established internal timelines.
Experience required:
Minimum 2 to 3 years experience in regulatory affairs
Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
Experience in submissions, MAA's, variations, renewals
Detailed knowledge of EU current registration requirements for dossier preparation and procedure running
Deep knowledge of specific national requirements in usual target registration countries
Knowledge of writing SOPs
Knowledge of IT tools utilised in RA department
Package:
An excellent salary of between €40,000 and €50,000 depending on experience is on offer. An excellent benefits package including health insurance, 7.5% employer contribution for pension, significant bonus, 23 days annual leave and flexibility around start and finishing times is offered. This is a permanent role.
Interviews will be immediately (first round phone interview followed by one face to face). If you are interested in this role please send me Adele Moran an updated CV for immediate consideration or call me on for more information.