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
