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.