Regulatory Affairs Specialist

Hrm

Galway

Our client is a global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life. They have 250 staff on-site in Galway with this to expand due to on-going product development and new products being introduced on site. The Role: You as the RA Specialist will join a team of 6 with you reporting directly into the Director of Regulatory Affairs. The role will focus on new submissions worldwide for products developed within the organisation as well as supplements/variations to transfer manufacturing processes between manufacturing sites. This role will be based at the organisations Galway site and will offer a dynamic fast-paced environment. Key Responsibilities: Life cycle management and regulatory filing maintenance activities. New Product Submission Activities; Preparation of registration submissions, in CTD format, for approval by the US FDA, European Regulatory Authorities and worldwide, as required. Make updates to departmental procedures to foster an environment of continuous improvement. Administrative support in the preparation of regulatory documentation for global submissions (hard copy and electronically), communicate submission schedule to the e-submission group and perform quality checks on documentation at the time of submission of dossiers. This includes filing, archiving, photocopying and scanning of regulatory documentation. Perform literature searches and order publications from libraries. Coordinate regulatory activities, this includes scheduling meetings, preparing presentations, conference calls set up and record minutes, management of regulatory information systems, i.e. excel spreadsheets, databases, web-based document management systems (Microsoft sharepoint. The Person: A minimum of a Bachelor's degree (or equivalent) in a science related discipline and 1-2 years regulatory experience in the pharmaceutical industry. Topra certification or RAC, preferred. Knowledge of the Ph.Eur, USP, 21 CFR and various FDA Guidance's for Industry. Knowledge of cGMP awareness and compliance. To discover more about this opportunity, apply now or contact Orla Boyle at HRM on 353 91 782110 for a confidential chat. This job originally appeared on RecruitIreland.com.

2080 days ago