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Job Title

Regulatory Submissions Management Profes


Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Submission Management Professional within the Regulatory Submission Management Department in Dublin. This is a contract role of 2 years duration initially. Key Responsibilities: As a Submission Manager your overall objective is to plan, manage and facilitate the delivery of submissions within a given product/portfolio. This position is the overall accountable and responsible for project managing individual submissions under an asset, from planning through to case closure. This position involves close collaboration with companys global submission sourcing partner. Your priority tasks will be: Planning and preparing the regulatory submissions pipeline for life-cycle maintenance activities. This includes liaising across regulatory content owners inside and outside RA and our sourcing partner; Monitoring progress performance via project plans in accordance with companys planning process; Authoring and reviewing Module 1 documentation; Coordinating the review of published outputs. Ensuring that dossiers are proactively submitted and tracked, and that relevant stakeholders are kept informed; Coordinating responses to health authority questions and commitments; In close collaboration with our sourcing partner, ensuring that companys information systems are updated with submissions details, and that documents are uploaded according to compliance and quality standards. Experience & Qualifications. Scientific Master degree, bachelor degree or similar work experience; 3 years or more experience working in Regulatory Affairs within different areas (CMC, Labelling, Clinical, Submission Management, Local RA or similar); Knowledge and preferably experience within Submission Management in relation to submission processes; Understanding of CMC and Labelling components for post-approval activities; Project manager skills required (communication, collaboration and presentation skills as well as Planning and delegation skills; strong ability to manage a submission pipeline, keep the overview and prioritise; strong drive and ability to execute according to plan. Furthermore, you are: a strong communicator, passionate and enthusiastic in your way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders. If you are interested in applying for this role please call Linda on +353 1 2784671 or email Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. This job originally appeared on


Dublin, Dublin West

Date Added

102 days ago