About Xeolas

Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 60+ employees. We develop and manufacture innovative patient friendly pharmauceutical 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 currently 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 primary 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 sites 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.
• Drive EHS continuous improvement initiatives.
• Design, implement and lead emergency plans and response capabilities for both Baldoyle and DCU.
• Maintains 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.

Minimum Requirements

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)
• Fluent English essential

Competencies: