Manager Regulatory Affairs API
Novartis
Job Description Summary En Sandoz, la calidad es un pilar clave para cumplir con nuestro propósito de facilitar el acceso a medicamentos de calidad para los pacientes.Como Regulatory Affairs Technician en nuestra planta de Palafolls tendrás como tarea principal la preparación de la documentación de registro (sea de nueva creación o bien el mantenimiento de los dossiers ya existentes) para el envío a las Autoridades Sanitarias y clientes y siempre asegurando que está en cumplimiento con las normativas aplicables de cada país.Job DescriptionAt Sandoz, quality is a key factor embedded in our purpose of pioneering access for patients.
As Manager Regulatory Affairs API in our Palafolls site, you’ll provide timely preparation of high-quality CMC regulatory documentation for active ingredients / intermediates under own responsibility; Formulate and lead global regulatory strategy for drug substances, under minor supervision.Your responsibilities will include:Under supervision, formulate and lead global regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance for drug substances under own responsibility.Responsibility for innovative solutions and independent deduction and management of more complex activities for gaining and maintaining the activities according to the legislation, guidelines, good practice, and business goals. * Professional and timely planning, authoring, reviewing, coordination and/or submission of regulatory CMC documents in cooperation with relevant stockholders
GP6What you’ll bring to the role:PhD/Master/BSC (natural science: chemistry, pharmacy, biology, or related subjects)Minimum of 2 years work-related experience or relevant experience in pharmaceutical industry GxP areas.Desirable: 4-8 years work-related experienceBroad knowledge on Module 3Broad knowledge of regulatory guidelinesGood knowledge of relevant software toolsGood skills in presentation and scientific/technical writingGood documentation skills and able to understand and exactly follow written proceduresSound knowledge on cGMPDesirable: Knowledge on sterile API registration#SandozSkills Desired Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance
Palafolls, Barcelona
Sat, 21 Sep 2024 07:48:31 GMT
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