My client is a global Pharmaceutical company with a primary focus on men and women's health. Their virtual operation is based in the heart of Dublin City Centre, with the majority of manufacturing happening in sites throughout Europe. The Dublin operation forms part of a wider global network and offers great opportunities for career development and professional growth.
Due to a strong development pipeline for 2021, they are seeking a Senior Regulatory Affairs Officer to join their dynamic team.
Some duties and responsibilities of the Senior Reg Affairs Officer will include:
- 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.
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).
You should have skills and experience in the following:
- 3+ years of pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions).
- 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.
- Experience of emerging markets / international RoW markets and regulatory filings.
- Quality control review of technical/ regulatory documents.
- Understanding of Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices.
My client is looking for someone with a positive can-do attitude in a growing company with expanding range of therapeutic product range and someone with the ability and interest to act as a mentor to junior colleagues and to assist in their training and development as appropriate.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.