Regulatory Affairs Manager

Dublin  ‐ Onsite
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Keywords

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.
Start date
07/2014
From
Real Staffing
Published at
18.06.2014
Project ID:
727681
Contract type
Permanent
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