Description
Regulatory Affairs Officer:A leading global pharmaceutical company based in Dublin is looking to hire a Senior Regulatory Submissions Officer 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.
Responsibilities:
- 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.
- Submit the Marketing Authorisation Applications (MAA) for assigned projects to Regulatory Authorities (MOH) in territory according to the annual registration plan and company's registration strategy.
- Proactive inform supervisor and other involved functions regarding all identified risk related to the planned MAA submissions for assigned projects.
- Support the process of scientific advice obtaining from MOH by liaison with Agency and preparation of all required data/documents.
Qualifications:
- Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
- 3 - 4 year experience in a regulatory affairs environment
- Detailed knowledge of EU current registration requirements for dossier preparation and procedure running
- Deep knowledge of specific national requirements in usual target registration countries
- General knowledge of the pharmaceutical industry
- Knowledge of Company's internal rules, SOPs and structure
- Knowledge of IT tools utilised in RA department
Package:
An excellent on experience is on offer along with an attractive benefits package including an impressive bonus and pension.
This is a permanent role and is placed in South Dublin, close to the m50 and very accessible via the Luas. Interviews will commence immediately so if you are interested in this Regulatory Affairs job please send an updated CV to Amanda Murphy for consideration or ring me on to discuss further.