Regulatory Co-Ordinator
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Job type: Full time, fixed term.
Salary: €34,256 per annum.
Location: Dublin
Overview:
- Supporting the Planning and Authorisations Manager & the Regulatory Case Manager in the management and on-going development of the team.
- Working in tandem with teams within the Veterinary Sciences Department (VSD), specifically the Safety and Efficacy Assessment team, the Pharmaceutical Assessment team and the Scientific Animal Protection team to ensure the effective and
efficient processing of activities. - Working closely with the team to ensure these teams have access to efficient and effective
administrative support. - Managing and developing the staff in the team of the VSD section.
- Working with colleagues in the VSD section to prioritise objectives and to ensure that the
strategic goals of the section are achieved. - Working with assigned team to organise, plan and manage work allocated to the team.
- Updating/writing SOPs and participating in audits when necessary.
- Monitoring progress and status of cases including adherence to timelines.
- Manage the quality and volume of output for the team including monitoring and improving quality standards.
- Compilation of statistical data analysis as required and reporting regularly on progress against specified targets and objectives.
- Ensuring that the procedures and policies of the Quality Management System are deployed and adhered to within the team.
- Working with the management team of the VSD section and other colleagues to develop and implement relevant policies and practices.
- Participating and managing the involvement of the team in any internal audits including the identification and implementation of any required corrective actions
- Ensuring that available information and knowledge across the company is effectively used by the team.
- Providing cover and support to the team when necessary.
- Working with the Planning and Authorisations Manager to set appropriate performance targets for the team.
- Working with the Planning and Authorisations Manager and other colleagues to promote effective performance within the team.
- Taking measures to identify and resolve issues impacting performance.
- Recognising good performance and promoting a culture of performance improvement within the team.
- Preparing individual training plans for inclusion in annual organisation training plan.
- Training and supporting new staff.
- Working with HR, Planning and Authorisations Manager, and other colleagues as required to manage recruitment and selection of the team.
- Liaising with HR to provide front line HR management of staff (e.g. managing flexi-time, annual leave, probationary reviews etc.)
- Ensuring the provision of high quality induction and ongoing training for staff, including on the job training.
- Overseeing the development of staff, including the development with HR, of individual training plans, and maintenance of training records and documentation.
- Provide timely feedback to team members.
- Representing the views of the team to the wider organisation.
- Working with team to ensure delivery of efficient and effective customer service.
- Ensuring responses to queries in line with the company service charter.
To be considered for this post, candidates must have:
- Ability to meet milestones/deadlines and reach targets.
- People management skills including ability to develop and motivate a team.
- Proven ability to manage high and diverse workloads.
- Excellent organisational skills including the ability to prioritise and manage applications.
- Excellent communication skills.
- Ability to be self-managing and use initiative when required.
- Good understanding of European, MR or National procedures.
- Good knowledge of workflow and information systems.
Consultant
Elizabeth Fenlon
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