TRABAJO REGULATORY AFFAIRS PRODUCT QUALITY BARCELONA, BARCELONA

Experiencia mínima de 2-3 años en roles de quality assurance y/o regulatory affairs en la industria farmacéutica... laboratorio, ubicado en la zona de barcelona...

Strong understanding of regulatory affairs globally    direct regulatory affairs cmc experience with submissions for synthetics and/or biologic and biotechnology...

Apply gxp principles according to the stage of product lifecycle... our chemistry, manufacturing, and controls (cmc) regulatory function spans across the product...

quality management system implementation: lead the establishment of quality management systems (qms), including procedures, work instructions, and templates, while...

Understanding of regional product registration processes, including gs1 standards... organizational skills in planning, strategizing, managing, and monitoring regulatory...

Work with internal & external customers to provide data and accurate regulatory input... prepare and update local sops to comply with all good regulatory practices...

Active participation in product development... organizes regulatory information, logs and tracking... participate in the product development and regulatory strategy...

Experience in regulatory affairs business processes is a plus (e... work together with a product squad in delivering the product’s roadmap...

Support responses to quality questions from regulatory health authorities... work closely with regulatory to develop effective regulatory and cmc strategies...

Your rolemaintain the product database... your skillsprevious experience in the legislation/regulatory affairs department is a plus... collaborate in the homologation...

Contribute to the development of real-world evidence strategies relevant to the mco and integrated evidence generation plans to support product development, regulatory...

Pmco,,  country operations line management, and quality group... following quality issue processes by escalating systematic or serious quality issues, data privacy...

•    ensure adherence to industry best practices, security standards, and regulatory requirements in the development and deployment of our iot solutions...

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs... previous demonstrated experience...

Define and manage standards, guidelines, and processes to ensure r&d data quality... ability to lead the governance of architecture decisions, ensuring compliance...

Strong understanding of regulatory requirements and guidelines for clinical trials, including ich-gcp and local regulatory requirements... in addition to your competitive...

This individual is able to lead, and direct biostatistics work either in house or partnering with cros to ensure delivery to quality and time...

Document user interactions and feedback to constantly improve processes and product offerings... handle multiple requests in parallel with the same level of quality...