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• Lifecycle management of approved regulatory files
• Documentation support in registration and renewal procedures
• Preparation of ASMF/DMF/CEP according to project timelines, ensuring compliance with regulatory requirements and facilitating submissions to the Authorities

• Lead technology transfers and new process introductions
• Support transfers and optimization of current processes
• Develop and maintain manufacturing documentation and risk assessments
• Technical support across the product lifecycle, including troubleshooting and process robustness

• Participation in global packaging transfer projects of commercial products
• Introduction of new pharmaceutical packaging processes
• Preparation of documentation for packaging material and finished pharmaceutical products
• Preparation of documentation for process transfer and registration documentation

Eltérések kivizsgálásának minőségbiztosítási oldalról történő támogatása, a területhez tartozó kivizsgálások felügyelete/koordinálása, részvétel a szükséges CAPA intézkedések meghozatalában, teljesülésük nyomon követésében....

• Lead and support MIA variation/update submission to Hungarian authority,
• Prepare documentation (QMS, SMF, QP declaration),
• Act as SME during regulatory review,
• Support GMP inspection readiness.
• Lead EU GMP inspection preparation,
• Act as contact for authorities,
• Support CAPA and responses.

• Setting strategic and operational standards for external engagements with Healthcare Professionals, Healthcare Organizations, and patient communities worldwide
• Leading a global organization of approximately 40 professionals
• Fostering psychological safety and coaching chapter and operational leaders

• Development and execution of country-level site engagement strategies across disease areas
• Building relationships with investigators and key operational stakeholders to enhance site satisfaction

• Project management of publication activities across prioritized disease areas
• Coordination and operational oversight for publication activities
• Management of end-to-end publication workflows, project timelines, and budgets across global disease areas

• End-to-end operational planning and execution of Roche events and engagements involving external healthcare professionals, healthcare organizations, or Patients/Patient Organizations
• Compliance management for Healthcare Professionals, patient partnerships, and Healthcare Organization interactions

Drive and facilitate end-to-end compliance process management for Healthcare Professional (HCP), Key Opinion Leader (KOL), and Patient Organization engagements across global structures...