Regulatory Affairs Associate CIS
Core
Ensure regulatory compliance across CIS markets (Azerbaijan, Turkmenistan, Georgia), manage product submissions and approvals, and maintain regulatory documentation for OTC and MD healthcare products.
Role type
Regulatory Affairs Associate
Builds
Product registrations, launches, and dossier management for consumer health brands
Domain
Consumer health / Pharmaceuticals / CIS regulatory environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submissions and dossier management, market authorization acquisition, label and packaging compliance review, regulatory risk analysis, cross-functional collaboration, regulatory database management, legal and regulation interpretation
Preferred skills
Experience in EAEU or non-EAEU CIS regions, scientific interpretation of technical information, strategic balancing of regulatory and business priorities
Technologies
Regulatory databases
Responsibilities
Engage with external regulatory environments in Azerbaijan, Turkmenistan, and Georgia; Prepare and manage regulatory documents and applications for new product launches and lifecycle maintenance; Obtain market authorizations and submit variations, renewals, and notifications; Review and approve product labelling, artwork, and promotional materials; Analyze regulatory issues and develop mitigation plans; Monitor regulatory changes and contribute to continuous improvement
Seniority
Junior to Mid-level, hands-on IC