Description
A Regulatory Affairs Manager is required to lead the European Regulatory Affairs team for a global Pharmaceutical company in Dublin. This is an exciting opportunity for a Regulatory Affairs Manager with strong people management skills to work in a busy and challenging environment where they can really thrive and have a sense of achievement.Submission Management
- Manage and oversee the coordination & preparation of registration processes for European Region
- Ensure that the documentation prepared/compiled by team is complete and complies with applicable regulatory requirements.
- Tracking the European region submission progress and MAs related data via setting efficient communication rules with national competent authorities/ local agents.
- Ensure that timely responses to the regulatory queries raised during the evaluation process are provided by the team to the national competent authorities/ local agents.
- Providing support to senior management in respect of registration strategy.
- Ensuring that the Change Control requests are assessed vs. ICH/EU requirement and regulatory impact assessment is performed and communicated.
- Develop & maintain regulatory knowledge of EU/ICH regulations.
- Lead cross function meetings and processes with regard to implementation of EU/ICH regulatory requirements, in order to obtain timely regulatory approvals for the products as part of the product development/registration strategy planning.
Departmental Management
- Overall management of a team of Junior to Senior Regulatory Affairs Officers.
- Motivate, inspire and assist coworkers to reach company goals by completing assignments and projects.
- Foster innovation - creative ways of doing things differently and more effectively.
- Maintains staff by recruiting, selecting, orienting, and training employees.
- Financial control of department including budget development, forecasting and control.
Experience Required
- Life Science degree and/or a minimum of 5 years EU Submissions experience
- People Management experience
- Understanding of eCTD requirements.
A competitive salary plus a benefits package is on offer. Interviews can be held immediately.
To be immediately considered for this role call me, Niamh Irwin, on or apply directly to this advert.