Regulatory Affairs Specialist_Temporary Replacement

JOB DESCRIPTION: Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross-functional teams. RESPONSABILITIES: Regulatory Submissions & Documentation Prepare, compile, revise, and submit global regulatory dossiers for new Marketing Authorization Applications (MAAs), variations, renewals, and lifecycle management activities. Collaborate in the preparation and/or revision of global regulatory submissions to ensure completeness, accuracy, alignment with company objectives, and compliance with the latest local and international regulations. Prepare documentation and submissions to Health Authorities, either directly or through local partners, ensuring regulatory compliance and supporting efficient product registration and maintenance. Support labelling and change control processes to ensure timely and comprehensive review and approval of packaging components (cartons, labels, Physician Insert, Patient Insert, Medication Guides). Manage other legal documentation required for registrations, such as Certificates of Pharmaceutical Product (CPPs). Maintain accurate and up-to-date regulatory documentation and regulatory files in accordance with global standards. Input regulatory intelligence, requirements, and submission data into relevant regulatory systems/databases, ensuring data accuracy and consistency. Regulatory Compliance, Strategy & Lifecycle Management Support the implementation of global regulatory strategies for assigned products to achieve regulatory approvals and maintain compliance throughout the product lifecycle. Advise and collaborate with cross-functional teams (R&D, QA, Manufacturing, etc.) on regulatory requirements to ensure successful market approval and lifecycle management. Contribute to regulatory intelligence activities and provide insights into the evolving global regulatory landscape. Regulatory Operations Contribute to the creation, maintenance, and improvement of the Regulatory Affairs Quality System, collaborating on the definition of processes and the implementation of global standard procedures. Maintain high-quality regulatory documentation and ensure compliance with procedural, regulatory, and system requirements across regions. Administrative and internal systems management (iPARTS, DACRA and any other tool). Knowledge Good knowledge of EMA, ICH, regulations and guidelines related to drug development, approval, and lifecycle management. Good knowledge of Extra EU countries' regulation is preferred. Strong organizational skills with the ability to handle multiple regulatory projects simultaneously and manage multiple stakeholders. Good commercial and product awareness. Strong administrative and systems background, including experience with regulatory databases and document management tools. Position Impact Simultaneous management of multiple global regulatory projects with several internal and external stakeholders. High impact on regulatory compliance and ensuring product availability in the market. MINIMUM REQUIREMENTS: Minimum 3 years of experience in Regulatory roles within the Pharmaceutical Industry. Good knowledge of EMA and ICH regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorizations. Good knowledge of Extra EU countries' regulation is preferred. Familiarity with eCTD submission, compilation, and publishing using specific tools. Good commercial and product awareness. Sound administrative and systems background. Ability to develop good cross-functional working relationships and tactical coordination of projects. xohynlm Fluent in English, spoken and written is a must.