EU Regulatory Strategy and Project Management Serve as the primary regulatory and scientific point of contact with the European Medicines Agency (EMA), national competent authorities in EU Member States, internal stakeholders, customers, consultants, and vendors. Develop and implement EU regulatory strategies and action plans in alignment with the company's overall R&D; and business objectives. Oversee the progress, quality, and delivery of all EU regulatory projects; Provide regulatory input to product development, commercialization, partnership discussions, and business-development activities. Lead the preparation, review, and quality oversight of regulatory documentation, including marketing authorization applications, responses to health authority questions, variations, renewals, and other lifecycle submissions. Establish and maintain effective working relationships with internal functions, including R&D;, Clinical Development, CMC, Quality, Pharmacovigilance, Medical Affairs, Commercial, and Legal teams. Manage external regulatory consultants and vendors to ensure activities are conducted efficiently and in compliance with EU requirements. Build and maintain professional networks with European regulatory agencies, consultants, and relevant external partners. Regulatory Operations,



Quality, and Budget Management Ensure effective governance, quality control, and compliance throughout the regulatory affairs process. Monitor EU regulatory project timelines, deliverables, costs, and resource allocation. Manage regulatory budgets and oversee cost utilization across EU projects. Ensure regulatory activities comply with applicable EU laws, regulations, guidelines, and internal procedures. Drive continuous improvement of regulatory processes, planning tools, and submission quality standards. Master's degree or above in Pharmacy, Medicine, Biology, or a related life science discipline. At least 10 years of relevant Regulatory Affairs experience in the pharmaceutical or biotechnology industry. Familiarity with GxP, ICH guidelines, and applicable quality and compliance requirements. Proven experience in regulatory risk assessment, feasibility evaluation, issue resolution, and strategic planning. Strong leadership, project-management, stakeholder-management, and cross functional collaboration skills. Ability to manage multiple complex projects and external resources in a fast paced, matrixed environment. Fluent written and spoken English.

📌 Regulatory Affairs Director (España)
🏢 Henlius USA
📍 España