This speciality pharmaceutical organisation focus on R&D and innovation in the space of women's and men's health. Due to a strong development pipeline for 2020, they are seeking experienced Reg Affairs Officer and a Senior Reg Affairs Officer to join their growing Regulatory team at their Dublin City Centre facility.
The Role
Duties and responsibilities of the 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
The Person
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 Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.
