Description
Regulatory Affairs Manager DublinMy client is currently seeking a regulatory affairs manager. This is a really exciting and varied role with a lot of scope and opportunity.
Key Tasks and Areas of Responsibility
Preparing and despatching suitable dossiers and data to designated registration agencies (EU and non EU) or licensees/customers to agreed company procedures and objectives
Responsible for preparing and maintaining regulatory aspects of manufacturing license/authorisation for the company in accordance with the guidelines laid down by national regulatory authorities (e.g. IMB, EMA,)
Responsible for maintaining regulatory aspects of the company's drug substance in accordance with the guidelines laid down by national regulatory authorities and managing any associated change controls.
Reviewing data to ensure suitability for submission
Registering new products in new territories in line with the company's marketing plans
Renewing and updating manufacturing licences/authorizations
Processing product licence and manufacturing authorization variations as required.
Updating regulatory documents according to agreed company strategies
Responsible for supporting the QA team in relation to Regulatory Affairs and Compliance in the context of the Group Quality Management System.
Responsible for maintaining an oversight of the registration requirements and Group activities in relation to other classes of products i.e. medical devices, cosmetics, biocides or medical foods both existing and arising from business development
DMF management
Dossier preparation for a line extension
You will be involved with a BEQ study (project managing it) but experience in this is not essential
Other responsibilities will include clinical support, product development support, database administration, budgetary planning and control
Experience required:
Degree in a science discipline, e.g. BSc or MSc or equivalent.
Minimum of 5 years experience with a pharmaceutical or similar organisation.
Experience with and a good understanding of the Regulatory Compliance activities
The ideal candidate will be versatile, will have a good range of experience, will be confident and be strong at communicating
Must be comfortable in dealing with others and working with different partners -Experience establishing and maintaining contact with key personnel in the various Regulatory agencies
Experience obtaining information and keeping up to date on regulatory rules and guidelines prepared by National Regulatory Agencies
Desirable experience:
In addition to pharmaceutical sector experience medical devices, food or cosmetic industry experience would really be of interest
Some clinical understanding would really stand out but is not essential
Global experience is highly advantageous
An excellent salary of €65,000 - €70,000 is on offer with an excellent benefits package. This is a permanent role. If you are interested in this role please contact me Adele Moran on . Interviews will be immediate.