La Faculty Completa




Rosalba Gregorini

Regulatory and Quality Assurance Manager

Experienced Regulatory and Quality Manager with a demonstrated history of working in pharmaceutical industries whitin international contexts and complex matrix organisations.

Skilled in international regulatory applications and requirements, biological drug products and Biotechnology, Clinical Trials, GxP matters, Audits & Inspections (AIFA, FDA, ANVISA, KFDA, CFDA, MoH Turkey, MoH Russia). Certified Qualified Person and Lead Auditor.

Strong professional & educational curriculum.

 

Responsible for:

  • new MA application / renewal / variations of brands and biosimilar products (biological, monoclonals antibodies, conventional DPI, pMDI, and oral solids drugs) through CP, DCP, MRP and national procedure applications; worksharing procedures, Scientific Advice;
  • publishing into Italian Official Gazette of MA variations;
  • dealing with HA for inspections, product recall, product shortage, DHPC, Q&A, Alerts, Survey, and tender bid submissions;
  • pricing & reimbursement dossier and negotiation with AIFA;
  • artworks and risk minimization measures (educational materials) development and submission;
  • clinical trials oversight to ensure compliance with GCP/ICH standards (Clinical Trial Application, AIFA / Ethic Committee submissions, leading of risk assessment, selection and qualification of CROs and IMP suppliers, review of agreements, contracts, protocols, IB, informed consent, CRF/eCRF, Sites' visits reports, clinical trial reports);
  • cross-functional interaction with affiliate, Head-Quarters and Business Partners stakeholders for the products launch strategies, and launch tasks follow up;
  • review and submission to AIFA of promotional materials;
  • support to the QPPV to ensure local Pharmacovigilance compliance;
  • compliance to regulations for the narcotic drugs ;
  • development and maintenance of the Quality Management System through maintenance of licensees, management of SOPs, Quality Manual, Change Controls,

Customer Complaints, Deviations, Training, Quality Agreements, Inspections, Audits, CAPAs follow up, monitoring of quality metrics & KPI, compliance risks;

  • fostering of relationships and professional contact with Business Partners and Services Providers to ensure that outsourced responsibilities are met;
  • oversight of co-marketing, co-promotion and licensing agreements and regulatory submissions, as applicable,
  • Regulatory Intelligence,
  • support to the Legal function for patents assessments and compliance objectives;
  • Budgeting.

 

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