Cache of job #13982793

Job Title

Regulatory Submissions Professional

Employer

CPL

Location

Dublin, Dublin South

Description

On behalf of my client, a leading Pharmaceutical company, I am recruiting for a Regulatory Submission Management Professional . This is a permanent role available within Dublin. within the Regulatory Submission Management Department in Dublin. As a Submission Manager you will work within the Regulatory Submission Management Department; planning, managing and facilitating the delivery of submissions within a given product/portfolio. You will be the overall responsible for project managing individual submissions under an asset, from planning through to case closure. Responsibilities will include but are not limited to: Manage and keep an overview of the Regulatory Submission Pipeline for life-cycle submission activities. Plan, prepare and drive submission strategies. Be an active part of the regulatory cross-functional focus team within a portfolio, representing Submission Management and acting as counterpart to other parts of Regulatory Affairs (RA) working within the same portfolio (e.g. RA CMC, RA Labelling and Regulatory Affairs Project. Monitor progress performance on the Regulatory Submission Plans and communicate goals, status, challenges, opportunities, risks as well as potential solutions to relevant stakeholders. Author and review Module 1 documentation. Coordinate the review of published output. Coordinate responses to health authority questions and commitments. Ensure that the company’s Regulatory Information Management System is updated with submissions details, and that documents are uploaded in the Document Management System according to compliance and quality standards. Desired experience & qualifications: Master’s Degree in a Scientific discipline, bachelor’s degree or similar work experience. 3 years’ or more experience working in Regulatory Affairs within different areas. (e.g. 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. Solid project management skills and experience from project managing regulatory activities/submission pipelines. Strong communication skills. If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. #THR2018. This job originally appeared on RecruitIreland.com.

Date Added

68 days ago

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