Regulatory Affairs Specialist
Core
Lead local medical team and execute regulatory strategies for pharmaceutical product lifecycle management in Romania.
Role type
Regulatory Affairs Specialist (Pharmaceuticals)
Builds
Marketing authorization applications, pricing approval documentation, and compliant product labeling/packaging for the Romanian market.
Domain
Pharmaceuticals / Healthcare / Regulatory Affairs
Required skills
Regulatory submission management, lifecycle management, health authority interaction, pricing documentation, labeling compliance, project management, attention to detail
Preferred skills
European regulatory procedures knowledge, change control management, continuous improvement
Technologies
Microsoft Office
Responsibilities
Ensure timely submission of marketing authorization applications; prepare regulatory documentation for renewals and variations; monitor approval processes with health authorities; participate in pricing approval applications; ensure accurate prescribing and packaging information; manage change control processes.
Seniority
Mid-level (3-5 years experience)