Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 60+ employees. We develop and manufacture innovative patient-friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Manager as we expand and broaden our range of non-sterile oral products. Reporting to: Engineering Manager / EHS Team Role Function: The health and safety officer will ensure that employees and the workplace adhere to safe practices and comply with current health and safety legislation. The role involves developing, monitoring, and implementing the company’s health and safety policy and procedures, conducting risk assessments and site inspections to identify and report potential hazards and controlling these hazards. They provide health and safety training courses for employees and contractors on site. Must be able to work with minimal direct supervision at all times based upon the experience, judgment and understanding of regulatory requirements, management systems and site objectives. This position is primarily based at the Baldoyle manufacturing facility with a requirement to work in DCU one day per week throughout 2025. Responsibilities: Oversees the development, planning, and implementation of health and safety policies; develops procedures used throughout the site. Serve as a part of site leadership teams to ensure EHS issues, systems and concerns are raised. Responsible for leading the development and implementation of site-wide Safety Strategy, to ensure regulatory compliance and commitment to reducing accidents and injuries. Develop and improve safety management systems to ensure the site is operated in a manner which meets the site's EHS standards. Attendance and participation in Tier management meetings ensuring Safety is first at all Tiers. Manage and report on EHS KPI's and reporting of metrics internally. Management of incident, accident and near miss management - follow up, investigation and reporting. Coordinate safety committees and safety activities onsite. Positively influence and collaborate with colleagues to enhance a self-sustaining safety culture. Conduct regular inspections and site audits, reporting findings to site and senior company management. Strict follow-up is required to ensure that actions are dealt with immediately. Develop and lead EHS initiatives across the site. Support all projects to integrate EHS requirements during implementation. Complete site Risk assessments on equipment, areas, new chemicals, and process steps. Completion of ergonomic risk assessments and VDU site assessments. Identify / provide / co-ordinate all EHS training on site, both internally and externally. Strict Management of all contractors on site from an EHS perspective. Review sub-contractors’ Safety Statements and RAMS prior to job commencing on site. Review plans and specifications for new equipment and participate in the management of change assessments. Design, implement and lead emergency plans and response capabilities for both Baldoyle and DCU. Maintain necessary EHS documentation in the form of data, reports, permits, policies, procedures and other written and electronic information necessary to maintain full compliance with applicable regulations and company policy. Provide leadership and guidance to key stakeholders on Process Safety related topics. Works closely with Manufacturing, Engineering and Quality to promote safe manufacturing practices. Stays abreast of new EHS government regulations as they are promulgated as well as new developments in industry. Maintain effective stock control of EHS consumables. Education / Experience / Skills: Knowledge and understanding of environment, health, and safety compliance reporting. Ability to make effective oral presentations and work as part of a team. To be a strategic thinker with a strong influential communication style together with the natural ability to develop cross-functional relationships. Proficiency in organizing, communication, problem solving, multitasking and collaborating with all levels and departments within the company. Bachelor’s degree in engineering / quality with a diploma in safety required. Manual Handling and VDU Instructor and Assessor (not essential). Thorough, diligent, good attention to detail. Collaborator with strong levels of engagement with individuals and team. High level of delivery and work completion. Good interpersonal and communication skills, verbal and written. Apply for this Job Please send a cover letter and your CV to #J-18808-Ljbffr
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 Affairs Senior Specialist as we expand. Overall Role Objective The Regulatory Affairs Senior Specialist will report directly to the Regulatory Affairs Manager and be involved in all aspects of regulatory affairs of the company including existing licensed products as well as products under development. Reporting To Manager Regulatory Affairs Requirements Preparation and maintenance of high-quality dossiers (marketing authorisation applications/ Response to Health authority questions/ post-approval submissions). Submission of CPP/ Manufacturing authorisation requests to HPRA/MHRA. Review of data intended for submission and advise regarding any deficiencies or issues. Ensure on-time submissions for all quality/ safety related changes for assigned projects. Preparation and submission of translated texts to EU/Non-EU countries. Update of databases and systems for all products (in-line with current SOPs). Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives. Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects. Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained. Embrace Xeolas values and behaviour. Support the Xeolas business by participating in project teams to support departmental initiatives. On an ad hoc basis, carry out additional tasks on behalf of Regulatory Affairs Manager. Key Skills / Experience Requirements For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Masters/ Bachelor's degree or equivalent in Science/Technology/ Pharmacy. Minimum 5 years of Experience in Regulatory. Capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions. Must possess organization skills, time management skills and attention to detail. Excellent critical thinking and problem-solving abilities. Strong interpersonal and communication skills. Experience in dealing with multiple stakeholders, both internal and external. Apply for this Job Please send a cover letter and your CV to #J-18808-Ljbffr
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 Please send a cover letter and your cv to #J-18808-Ljbffr
