Regulatory Affairs Associate Director - EU Regulatory Lead - FSP Client Dedicated
Core
Lead EU regulatory strategy and submissions for a dedicated pharmaceutical client, guiding product development from preclinical stages through registration and commercialization.
Role type
Senior IC Regulatory Affairs Associate Director (EU Lead)
Builds
Regulatory submissions and strategies for medicinal products
Domain
Pharmaceutical industry, EU regulatory framework
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EMA regulatory frameworks, end-to-end submission processes, orphan drug development, Paediatric Investigation Plans (PIPs), regulatory strategy, vendor management, budgeting/forecasting, contract modification management, project leadership
Preferred skills
Rapidly growing pharma organization experience, global regulatory landscape knowledge, medical terminology, statistical concepts
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Coordinate filing strategies with EMA/applicable agencies, oversee regulatory affairs vendors, provide post-approval regulatory leadership, monitor global regulatory changes, partner with medical/legal/quality/PV teams, manage project budgets, lead launch and review meetings, train junior team members
Seniority
Senior, hands-on IC with mentorship
