My client is an international leader in Men's and Women's health products and is currently going through an exciting time of growth and development.
With their Dublin hub being the home of their global RA, PV, Quality and Clinical teams, there is a requirement for a new Regulatory Affairs Officer to join their dynamic and expert RA team.
The RA officer will prepare, contribute to and manage International MAAs and Lifecycle activities for the current and actively growing range of pharmaceutical products, therapeutic indications and international markets.
- Preparation of submissions including; CMC variation filling, initial MAA filling, labelling updates, renewals, Marketing Authorisation Transfers (MATs), CMC authoring and \ or updates as required.
- Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, Globally based Regulatory Managers).
- Understands the Scope of Work, timelines and deliverables for a given project.
- Prepare status reports and metrics for assigned projects.
- Minimum of a BSc in Pharmacy or life science-related degree and at least 2 year's relevant human pharmaceutical experience with a focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets.
- Experience in preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.
- Experience of EU DCP and MRP MAAs.
- Ability to work to tight timelines and manage peaks in workload.
- Good team player with local Dublin based and internationally based colleagues.
- Positive can-do attitude in a growing company with an expanding range of therapeutic product range.
For a confidential discussion contact Helena Boyle on (01) 6321870.