Regulatory Affairs CMC Specialist

Position Overview We are seeking a highly motivated Regulatory Affairs CMC Specialist to join our Regulatory Affairs team at Helsinn Birex Pharmaceuticals Ltd, based in Dublin 15. In this role, you will support the management and maintenance of Marketing Authorisations (MAs) in compliance with European and international regulations. You will work closely with regulatory authorities, internal stakeholders, and external partners to ensure the smooth lifecycle management of our pharmaceutical products. Key Responsibilities Prepare and submit Marketing Authorisation Applications (MAAs), variations, renewals, and post-authorisation activities in line with European regulatory requirements. Manage communications and respond to queries from regulatory authorities (EMA, EU and non-EEA competent authorities). Publish dossiers and submissions using validated document management systems and ensure correct electronic formats. Ensure compliance between authorised Marketing Authorisations and manufacturing site procedures. Review and evaluate proposed changes related to quality, manufacturing, supply chain, and Contract Manufacturing Organisations (CMOs). Review and approve product artwork to ensure regulatory compliance. Liaise with Helsinns corporate office and licensing partners to support regulatory activities. Manage correspondence and compliance activities with the HPRA, including manufacturing and active substance registrations. Review GMP documentation (specifications, batch records, analytical methods) related to regulatory compliance. Maintain up-to-date regulatory status information and circulate regulatory approval notices internally. Contribute to continuous improvement initiatives within Regulatory Affairs. Adhere to company policies, cGMP, EHS, and quality standards. Required Qualifications and Experience Bachelors degree in Pharmacy, Chemistry, Life Sciences, or a related discipline. Minimum 5 years of experience in pharmaceutical regulatory affairs, with a focus on CMC (Chemistry, Manufacturing, and Controls) activities. Proven experience preparing and submitting Marketing Authorisation Applications and related documentation in the EU. Knowledge of EU pharmaceutical regulations, EMA guidelines, and experience liaising with regulatory authorities. Familiarity with GMP and quality systems in a pharmaceutical manufacturing environment. Experience using electronic document management and publishing systems. Strong attention to detail and organisational skills. Excellent written and verbal communication skills in English. Ability to work independently and collaboratively within a team. Key Competencies Regulatory Knowledge : Strong understanding of regulatory frameworks applicable to pharmaceutical products in the EU and internationally. Analytical Thinking : Ability to evaluate complex data and regulatory requirements effectively. Communication : Clear and professional communication with internal teams, regulatory authorities, and external partners. Project Management : Ability to manage multiple tasks and deadlines while maintaining high-quality standards. Problem Solving : Proactive in identifying issues and proposing compliant solutions. Teamwork : Collaborative approach to working with colleagues and cross-functional teams. Integrity & Ethics : Commitment to confidentiality, compliance, and ethical conduct. Adaptability : Flexible and responsive to changing regulatory requirements and business needs. Skills : Regulatory Affairs CMC Marketing Authorisation Applications Pharma GMP Pharmaceutical Regulations Benefits : Health Insurance Performance Bonus Pension Scheme Parking Space with EV Charger Flex Time Work from Home Scheme