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.
* Lead and coordinate EU registration activities for company products, including pre-marketing authorization and post-approval lifecycle management activities, where applicable.
* Oversee the progress, quality, and delivery of all EU regulatory projects; proactively identify challenges, assess risks, and drive resolution plans.
* 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.
* Coordinate and support regulatory authority inspections, audits, and related preparation activities.
* 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. Qualifications
* 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.
* Strong knowledge of EU pharmaceutical regulations, registration pathways, and technical guidelines, including EMA and EU Member State requirements.
* Thorough understanding of the end-to-end drug registration process and experience in authoring, reviewing, and managing regulatory submission dossiers.
* Familiarity with GxP, ICH guidelines, and applicable quality and compliance requirements.
* Demonstrated experience communicating and interacting with EU regulatory authorities, including EMA and/or national competent authorities. Experience with other health authorities, such as the NMPA or FDA, is preferred.
* 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. Proficiency in additional European working languages is a plus. #J-18808-Ljbffr

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