The Regulatory 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. SPECIFIC RESPONSIBILITIES Reporting To: Manager Regulatory Affairs Key responsibilities of Regulatory Associate Provide support on dossier compilation activities for EU/ ROW regions Provide support for regulatory dossier submission/ variations/ response to questions Provide support 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 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. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager. KEY SKILLS / EXPERIENCE REQUIREMENTS B.Sc. or related degree in Health Sciences or equivalent relevant experience and training. 1-3 years pharmaceutical regulatory industry/ eCTD publishing activities Understanding of regulatory affairs, applicable regulations and guidelines documents