Lavipharm

Compliance

• Execute routine regulatory activities: renewals, variations, CTD/Module 1 preparation
• Monitor and manage timelines for MA variations, post-authorization activities and renewal applications
• Prepare and submit import/export applications for medicinal products
• Review and update packaging materials and artworks in line with current guidelines
• Maintain regulatory databases and departmental filing systems

Officer, Regulatory Affairs – Lifecycle Management

• Lead regulatory strategy and lifecycle activities (renewals, variations, CTD maintenance) across a multi-country product portfolio
• Direct preparation and submission of dossiers, managing complexity with minimal escalation
• Interact and negotiate directly with EU and international regulatory authorities on post-authorization activities, variations, and renewals
• Formulate RA policies and ensure compliance across pharmacovigilance, packaging, and promotional materials
• Collaborate across functions with key internal stakeholders and mentor junior team members

Lead Regulatory Affairs, Lifecycle Management

• Leads preparation, review and compilation of CTD/eCTD dossiers for new product applications (MAAs and MATAs)
• Authors and reviews Module 1 documentation with minimal supervision, including regional/administrative content
• Contributes to regulatory submission strategy and drives proactive project completion
• Liaises directly with regulatory authorities during evaluation phases; prepares responses to questions and requests for information
• Coordinates across functions with key internal stakeholders to ensure dossier completeness and guideline compliance

Senior Specialist, Regulatory Affairs – Pre-Authorization Submissions

QA Engineer

• Follows international standards and complies with regulations
• Issues the annual "Product Quality Review" of all products
• Follows up the monthly stability studies of the QC Department and issues the relevant stability protocols and reports
• Ensures standard operating procedures and manufacturing documentation for all products is kept up to date
• Issues Process and Cleaning Validation Protocols, in accordance with the applicable Guidelines
• Evaluates the Plant and Laboratories for compliance with GMPs standards
• Reviews production batch documentation
• Issues, revises and reviews Standard Operating Procedures (SOPs) for the QMS system
• Issues, follows up and archives investigation of quality complaints with customers and suppliers
• Implements statistical evaluation studies for product release, shelf life and yield specifications
• Issues, follows up and archives investigation of quality deviations with the collaboration of the impacted department
• Issues, prepares, archives and follows up the change management system
• Issues, follows up and archives corrective and preventive actions
• Implements a thorough training program for all employees in the site

Officer, Regulatory Affairs – Lifecycle Management

Lead Regulatory Affairs, Lifecycle Management

Senior Specialist, Regulatory Affairs – Pre-Authorization Submissions

Quality Assurance Officer