My client is a global Pharmaceutical company with a primary focus on men and women's health. They are operating virtually in Dublin currently with the majority of manufacturing happening in sites throughout Europe. Their 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 2020, they are seeking an experienced Senior Regulatory Affairs Officer to join the team at their Dublin City Centre facility.
Duties and responsibilities of the Senior Reg Affairs Officers 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
- Act as responsible Regulatory Team member for assigned regulatory projects
- Prepare and/or review regulatory documentation for DCP, MRP and National applications in line with assigned timelines
- Actively participate and employ effective communication practices with internal customers
- Understands the Scope of Work, timelines and deliverables for a given project
- Prepare status reports and metrics for assigned projects
- Learn, develop and train
You will have skills and experience in the following:
- BSc / Pharmacy degree
- 2-4 years 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
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.