Our client, a pharmaceutical company based in Dublin are now actively recruiting for a Manager, Regulatory Submissions Management. This is a senior post within the organisation. It is permanent and based in Dublin.
The primary focus of this role is to lead & develop the direct reports within the section and ensure that the department objectives are met and implemented according to agreed management KPIs. The Manager of Submission Management Dublin drives performance excellence and deliverables in the Section to ensure Regulatory compliance within area of responsibility.
Key Aspects of the Role Include:
Ensure delivery to Asset targets Follow up on team objectives to ensure they are met and strategies are implemente Responsible for giving input to the Regulatory Operations budget in collaboration with Head of Submission Management Communicate decisions and initiatives within the team and in cooperation with stakeholders Ensuring deployment of company strategies and targets/KPIs Ensure Submission Execution and Lifecycle Management is in compliance with current regulations and business needs internally and with Sourcing Partne People managing the direct reports Building project management and knowledge sharing capabilities in the Submission Management department Enhancing regulatory and product lifecycle understanding and ways to transfer it into regulatory activities in the department Securing the necessary training and development of employees Provide employees with the needed support to drive performance
Experience & Qualifications
B.Sc. or equivalent third level qualification Minimum of 5 years' experience in the pharmaceutical industry. Training within management and leadership (e.g. courses or diploma degree). 2+ years' experience within management - resource management, capacity management, target management, performance management, competency development, motivation of employees, situational management etc. 3+ years of experience working within different areas of Regulatory Affairs Overall knowledge of Pharma and interfacing functions Good understanding of key regulatory business processes, & ability to implement and support these Good communicator and collaborator
For more information and to apply for this role please call Linda on 1 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1