.Life Science Consultant (Regulatory Affairs/QA) SpainPermanent JobOverview: As a Regulatory and Quality Assurance Consultant in the life sciences industry, you will play a pivotal role in advising clients on regulatory compliance and quality management strategies to ensure the safety, efficacy, and quality of pharmaceuticals, biologics, and medical devices. You will collaborate closely with clients to navigate complex regulatory landscapes, optimize quality systems, and mitigate compliance risks, ultimately contributing to the successful development, registration, and commercialization of healthcare products.Responsibilities:Regulatory Compliance:Provide expert guidance on regulatory requirements governing the development, registration, and marketing of pharmaceuticals, biologics, and medical devices in key markets such as the United States (FDA), European Union (EMA), and other international jurisdictions.Assess regulatory pathways and develop strategies for product approvals.Quality Management Systems (QMS):Evaluate and optimize clients' quality management systems (QMS) to ensure compliance with applicable regulations and industry standards, such as ISO 13485 and Good Manufacturing Practice (GMP) requirements.Conduct gap assessments, risk assessments, and internal audits to identify areas for improvement and implement corrective and preventive actions (CAPAs) as needed.Regulatory Submissions and Documentation:Prepare, review, and submit regulatory documents and dossiers required for product registrations, including investigational new drug (IND) applications, premarket approval (PMA) submissions, and technical files.Ensure the accuracy, completeness, and timeliness of regulatory submissions in accordance with regulatory requirements and internal quality standards.Quality Assurance and Compliance Audits:Plan and conduct audits of manufacturing facilities, contract research organizations (CROs), and suppliers to assess compliance with regulatory requirements, quality agreements, and contractual obligations.Generate audit reports, track audit findings, and collaborate with stakeholders to implement corrective actions and drive continuous improvement.Regulatory Intelligence and Strategy:Monitor changes in regulations, guidelines, and industry trends to provide proactive regulatory intelligence and strategic guidance to clients.Anticipate potential regulatory risks and challenges, and develop mitigation strategies to ensure regulatory compliance and business continuity.Training and Education:Develop and deliver training programs and workshops on regulatory compliance, quality management, and best practices to enhance clients' regulatory and quality capabilities.Serve as a subject matter expert and resource for internal teams and stakeholders on regulatory and quality-related matters.Qualifications:Bachelor's degree or higher in a life science, engineering, or related discipline
