Regulatory Affairs Associate Director - EU Regulatory Lead - FSP Client Dedicated
Core
Lead EU regulatory strategy and execution for a dedicated pharmaceutical client, guiding product development from preclinical stages through registration and commercialization across Europe and select territories.
Role type
Senior IC Regulatory Affairs Associate Director (EU Lead)
Builds
Regulatory submissions and strategies for medicinal products
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Required skills
EMA regulatory frameworks, end-to-end submission management, orphan drug development, Paediatric Investigation Plans (PIPs), regulatory strategy, vendor management, budgeting/forecasting, contract modification, global regulatory landscape interpretation
Preferred skills
Rapidly growing pharma organization experience, medical terminology, statistical concepts, ICH guidelines, CMC, clinical trial authorization
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Coordinate filing strategies with EMA/applicable agencies, oversee regulatory affairs vendors, provide post-approval regulatory leadership, manage project budgeting and forecasting, identify out-of-scope contract activities, collaborate on pricing and new business proposals, lead project teams and training, ensure compliance with SOPs/WPDs
Seniority
Senior, hands-on IC with strategic oversight