Regulatory Project Manager, New Registration CMC, CMC Excellence. Leads key activities to progress career in a professional team playing crucial role in maintaining GSK portfolio on the markets.
Requirements
- Independently assesses, manages, and/or drives the CMC submission deliverables
- Coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents
- Understands internal and external Regulatory environment
- Ensures adequate interaction and partnership with Senior Stakeholders
- Ensures adequate contribution during interactions with Worldwide Regulatory Authorities
- Authors responses to Regulatory Agency questions
- Identifies risks associated with submission data and information packages
- Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes
- Ensures information submitted in marketing applications meets CMC and regional requirements
- Communicates complex regulatory issues across GSK and with external agencies and third parties as necessary
Benefits
- Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office)
- Established job in an international, well-known pharmaceutical company
- Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets
- Opportunity to work within GSK standards and documentation applied globally
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
- Supportive & friendly working environment
