• Supports the Global labelling team to ensure that local labels are compliant with the Company Core Data Sheet or deviation documentation as required by internal procedures
• Prepares and updates labeling and artwork in compliance with regulatory requirements and internal procedures in the event of labeling changes.
• Manages SOPs, change controls and deviations owned by regulatory within the quality management system (QMS) and ensures that all regulatory processes and procedures are appropriately documented; where required, acts as subject matter expert (SME)
• Ensures all local submission/application correspondence is appropriately communicated, filed and archived as per SOPs/policies
• Reviews local promotional and non-promotional items according to applicable SOPs/policies
• Monitors local regulatory environment intelligence and advises GRA on the local regulatory impact
• Plans local RA budget
• Manages local vendors supporting the regulatory function
• Invoice and PO management

Other Responsibilities

• Provides input into clinical trial strategies as required
• Participates in inspections, audits
• Participates in Compassionate Use Program, EAP or post-trial access management
• Provides training on specific regulatory frameworks
• Performs other country-specific tasks in accordance local regulatory requirements

Qualifications

• Mandatory experience in regulatory submissions to Swissmedic (at least 2-3years)
• In-depth knowledge of the regulatory framework in the Alpine region, with a focus on Switzerland
• Strong understanding of the EU regulatory framework for centrally authorized medicinal products
• Experience with document management, artwork and e CTD submission systems
• Excellent interpersonal skills with a proven ability to collaborate across cross-functional teams
• Ability to work independently and efficiently under time pressure
• Fluent in both German and English