Tipo de jornada
Sin especificar
Tipo de contrato
Sin especificar
Salario
50.000€ - 60.000€ bruto/año
Estudios mínimos
Sin especificar
Descripción del empleo
- Vaccines - Local RA
- 1 Year Contract
International Pharmaceutical Company
- Ensure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.
- Work with internal & external customers to provide data and accurate regulatory input.
- Prepare & review labelling/Packaging texts and information brochures and communication activities.
- Run regulatory local projects meeting timelines and costs
- Understand relevant legislative and regulatory guidance applicable to activities
- Prepare risk benefit analysis
- Active involvement in concepts of regulatory strategy
- Attend industry and RA meetings
- Communicating with local regulatory agencies and document communication
- Provide local RA support to local Sales, Customer Services, QA, LSO, Medical and Marketing depts.
- Prepare and update local SOPs
- To comply with all Good Regulatory Practices, refer to formalized, mandatory policies that define common and transparent rules for regulatory agencies.
- To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and Others.
- To control and maintain your personal training folder.
- To comply with all Company policies and procedures.
- To follow a code of conduct conducive to a professional environment
- Flexible hybrid model
- Flexible shift
- Barcelona based
- 1 year contract
Requisitos mínimos
- Life sciences degree related to the activity Minimum of 8 years in the regulatory pharmaceutical field (preferred experience with biological products)
- Demonstrated ability to write good quality documents
- Highly PC literate
- Project management abilities
- Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
- Fluency in English language
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