Position Overview We are seeking a skilled and experienced Regulatory Affairs Manager to join our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, using expert regulatory CMC capabilities to provide regulatory guidance to the team. This position requires a combination of teamwork with hands-on involvement in regulatory operations, with a particular focus on GMP compliance, regulatory quality assurance, and regulatory CMC-related activities to support our manufacturing site. This position requires management of a small regulatory team. Key Responsibilities Team Leadership: Lead, develop, and manage the local Regulatory Affairs team to ensure high performance, collaboration, and compliance with training and development plans by providing guidance, support, and decision-making assistance. Support team development through mentoring and knowledge sharing. Manage departmental budgets and resource allocation to support current and future regulatory requirements. Regulatory Operations: Plan, oversee, and actively support the submission of new Marketing Authorisation Applications (MAAs), variations, renewals, and other post-approval activities in the territories assigned, according to the global strategies. Handle complex regulatory submissions and provide hands-on support for critical projects. Ensure timely and compliant submissions to EU or other international regulatory agencies, using validated publishing tools. Regulatory CMC Manage and maintain a comprehensive overview of Modules 2.3 and 3 of the dossiers across all applicable territories. Participate in change control processes to assess the regulatory impact of proposed changes to products, manufacturing processes, or facilities. Track and evaluate the impact of the CMC changes across different markets. Lead the preparation and review of the CMC documentation for the products manufactured on site, including the adaptation of CMC sections to meet the specific regulatory requirements of various territories. Handle complex regulatory submissions and provide hands-on support for critical projects. GMP and Regulatory Quality Assurance: Maintain regulatory compliance between registered MA dossiers and manufacturing/site operations. Oversee compliance with regulatory requirements for manufacturing, packaging, testing, and distribution activities. Review and approve from a regulatory point of view, when necessary, GMP documentation, product artworks, and other regulated documents. Support Quality Assurance during inspections and audits. Ensure alignment between regulatory commitments and site operations. Support preparation of responses to Health Authorities queries, in collaboration with other functions, other Helsinn affiliates and/or partners as appropriate. Compliance Management: Monitor regulatory changes affecting manufacturing operations and implement updates to processes and procedures as necessary. Support organizational changes and process improvements from a regulatory perspective Authority Interactions: Serve as the primary contact as MAH representative for interactions between HBP with regulatory authorities (e.g. HPRA, EMA), including attending meetings, managing correspondence, and preparing responses to queries. Cross-functional Collaboration: Collaborate closely with Corporate Global Regulatory Affairs to align local activities with global regulatory strategy. Work closely with Quality, Manufacturing, Supply Chain, R&D, and Commercial teams and provide regulatory guidance and expertise to internal stakeholders. Provide regulatory support to internal and external stakeholders, including provision of documentation, submission guidance, and communication of regulatory changes. Required Qualifications and Experience A degree in Pharmacy, Life Sciences, or a related discipline. Postgraduate qualifications in Regulatory Affairs or Pharmaceutical Sciences are advantageous. Minimum of 7 years of relevant experience in Regulatory CMC within the pharmaceutical industry for European or global activities. At least 4 years of experience in CMC regulatory writing and preparing documentation is desirable. Experience in Regulatory Quality Assurance is highly desirable. In-depth knowledge of European regulatory requirements (CP, DCP, MRP, national procedures) and familiarity with ROW markets is a plus. Strong understanding of GMP, GDP, and pharmaceutical quality systems. Previous experience supporting regulatory inspections (GMP, GCP, or regulatory audits). Proven experience in project management and cross-functional collaboration. Key Competencies Strategic and analytical thinking with a proactive approach to regulatory challenges. Hands-on approach to regulatory activities with attention to detail. Excellent communication skills, both written and verbal, with experience interacting with health authorities. Demonstrated ability to manage multiple projects and deadlines in a dynamic environment. High attention to detail and commitment to regulatory excellence and compliance. Problem-solving skills with a focus on practical solutions. Important interpersonal and managerial skills, with a focus on team mentoring and development. Helsinn Birex Pharmaceuticals - we are a global pharmaceutical company and a leader in supportive care focused on improving the health and quality of life of patients with cancer and chronic diseases. For more information, please visit our company website ( Skills: Regulatory Affairs CMC Benefits: Health Insurance Performance Bonus Pension Scheme Parking Space with EV Charger Flex Time Work from Home Scheme