• Vaccines - Local RA
• Madrid or Barcelona based

¿Dónde vas a trabajar?

International Pharmaceutical Company

Descripción

• 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

¿A quién buscamos (H/M/D)?

• 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

¿Cuáles son tus beneficios?

• Flexible hybrid model (up to 4 days home office), during trial period non applicable.
• Flexible shift
• Madrid or Barcelona based
• Social benefits