(Mdq-345) Interim Senior Regulatory Affairs Officer

Responsibilities: 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.Communicate with local regulatory agencies and document communication.Provide local RA support to local Sales, Customer Services, QA, LSO, Medical and Marketing departments.Prepare and update local SOPs.Comply with all Good Regulatory Practices, referring to formalized, mandatory policies that define common and transparent rules for regulatory agencies.Carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and others.Control and maintain your personal training folder.Comply with all Company policies and procedures.Follow a code of conduct conducive to a professional environment.Minimum Requirements: 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.Company Information: International Pharmaceutical Company
- Flexible hybrid model
- Flexible shift
- Barcelona based
- 1 year contract

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