Executive - Regulatory Affairs
Core
Support product submissions (new applications, variations, renewals) for EU & RoW markets to ensure supply in accordance with government legislation and guidelines.
Role type
Executive Regulatory Affairs (Pharmaceuticals)
Builds
Regulatory dossiers, SmPCs, labeling, and response packages for Health Authorities
Domain
Pharmaceuticals / Inhaled Anesthetics / Hospital Generics
Required skills
Regulatory documentation preparation, Change control management, RFI response authoring, Document management, Regulatory strategy definition, Cross-functional collaboration
Preferred skills
European market experience, Rest of World territory experience, Scientific background (Pharmaceuticals)
Technologies
SmartSheet, SharePoint, MasterControl
Responsibilities
Preparation and submission of regulatory documentation for new marketing authorisations, variations and renewals; Prepare and review new applications and submissions for compliance; Initiate change controls; Act as liaison between project teams; Author and review response packages to RFIs from Health Authorities; Collaborate with Artwork/Labeling teams for labeling updates and artwork changes; Responsible for regulatory data management; Define regulatory submission strategies; Provide updates on regulatory landscape changes.
Seniority
Executive, hands-on IC