Regulatory Affairs Senior Specialist
Core
Senior Regulatory Affairs Specialist ensuring new product registrations, line extensions, and compliance with local regulations for Medicinal Products, Cosmetics, Commodities, and Medical Devices across Europe/Middle East/Africa.
Role type
Senior IC Regulatory Affairs Specialist
Builds
Regulatory submissions and compliance for new drug applications, cosmetics, medical devices, and food supplements
Domain
Healthcare / Consumer Health / Regulatory Affairs
Required skills
Regulatory strategy, submission management, compliance monitoring, documentation assessment, claim/labeling review, audit support, process improvement, SOP maintenance
Preferred skills
Knowledge of local regulatory frameworks, understanding of medical/safety/quality requirements, ability to anticipate regulatory changes
Technologies
Regulatory systems, SOPs, artwork review tools
Responsibilities
Provide regulatory input and technical guidance to product development teams; Assess acceptability of quality, preclinical, and clinical documentation; Prepare and submit regulatory submissions; Monitor progress of regulatory authority review processes; Maintain awareness of current regulations and implement corrective actions; Review and approve promotional materials and product artworks; Support internal and external audits and inspections
Seniority
Senior, hands-on IC