Regulatory Operations Associate

3 weeks ago

Dublin, Dublin City, Ireland Xeolas Full time

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 Objective

The 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 To

Manager Regulatory Affairs

Key responsibilities of Regulatory Operations Associate
  • Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions
  • Responsible 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 applicable
  • Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
  • Maintain 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 tracking
  • Assemble 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 software
  • Perform 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 required
  • Provide technical support and guidance on eCTD publishing tools and software
  • Stay updated on changes in regulatory requirements and submission standards
  • Train and mentor staff on eCTD publishing processes and best practices
Key Skills / Experience Requirements
  • B.Sc. or related degree in Health Sciences or equivalent relevant experience and training.
  • 3-5 years pharmaceutical regulatory industry / regulatory operations experience
  • Experience working with current eCTD standards is required
  • Understanding of applicable regulations and guidelines documents
Apply for this Job

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