Senior Specialist, Regulatory Registration and Compliance
Core
Prepare and manage marketing authorization (MA) submissions for medicinal products, including local administrative documents, quality control, and linguistic input for Product Information.
Role type
Senior Specialist, Regulatory Registration and Compliance
Builds
Marketing authorization submission packages for pharmaceutical clients
Domain
Pharmaceutical industry, Regulatory Affairs (EU and global)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Knowledge of EU regulatory area and legal requirements, Organizational skills for multi-project management, Advanced English (written and verbal), Experience with regulatory databases and dossier management software
Preferred skills
Experience with centralized procedures
Responsibilities
Prepare and manage marketing authorization (MA) submissions, Provide ad hoc regulatory advice on post-authorization packages, Review and provide linguistic input for local Product Information, Serve as primary contact for regulatory affairs with national competent authorities, Collect and manage regulatory intelligence, Propose marketing authorization strategies
Seniority
Senior, hands-on IC
