Our client is a well known healthcare innovator organisation employing upwards of 90,000 people with an extensive portfolio of products. An opportunity has arisen for an experienced Regulatory professional to join their Regulatory team in South Dublin on a permanent basis.
Reporting to the Head of Regulatory Affairs the main objectives for this role are:
- Ensuring regulatory compliance and delivery of the local regulatory milestones for a defined range of pharmaceutical products for Ireland and within the EU
- Contributing to submission standards, contribute to local updates to ensure compliance standards and training are maintained in line with local standards and global SOPs
- Managing electronic and paper archiving systems ensuring alignment to country requirements and internal SOPs
The successful candidate will possess the following:
- A degree (BSc/MSc/PhD) in Science, Pharmacy or related
- Regulatory Affairs experience within the pharmaceutical sector
- Experience in Irish/European Drug registration activities
- Knowledge of EU and national regulatory requirements
- Ability to prepare high quality regulatory submissions
- Eligible to live and work within the EU
- Performance Bonus
- Life Assurance
To discover more apply online or call Gillian McMurrough directly on +353 1 6321827 for a confidential discussion.