Dublin, Ireland - Permanent Full Time Role
Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees.
We develop and manufacture innovative patient friendly pharmaceutical products for international markets.
We are now seeking an experienced Regulatory Operations Associate as we bring in-house publishing.
Overall Role ObjectiveThe Regulatory Operations Associate will report directly to the Regulatory Affairs Manager and will have a range of responsibilities focused on ensuring the accurate and timely submission of electronic regulatory documents for existing licensed products for life cycle maintenance and new submissions.
Reporting ToManager Regulatory Affairs
Key responsibilities of Regulatory Operations AssociateProvide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissionsResponsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic), as applicablePreparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time linesMaintain submission components associated with a regulatory submission, paper and/or electronic, as required.
This may include, but is not exclusive to, setting up templates, updating procedures, and project trackingAssemble electronic and paper Regulatory Submissions and packages for European, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using Lorenz softwarePerform quality review on submission documents to ensure accuracy and completeness.Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when requiredProvide technical support and guidance on eCTD publishing tools and softwareStay updated on changes in regulatory requirements and submission standardsTrain and mentor staff on eCTD publishing processes and best practicesKey Skills / Experience RequirementsB.Sc.
or related degree in Health Sciences or equivalent relevant experience and training.3-5 years pharmaceutical regulatory industry / regulatory operations experienceExperience working with current eCTD standards is requiredUnderstanding of applicable regulations and guidelines documentsApply for this JobPlease send a cover letter and your cv to
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