Senior Regulatory Manager

1 mese fa

Rome, Italia CSL A tempo pieno

CSL Vifor is a leading biopharmaceutical company dedicated to improving the lives of patients with rare diseases and nephrology conditions. We are currently seeking a dynamic Senior Regulatory Manager to drive regulatory affairs in our Italian affiliate with base in Rome. This role offers a unique opportunity to make a significant impact on the healthcare landscape in Italy while driving forward our mission of advancing patient care. In this role you will be part of the Italian Medical Team, reporting to the Medical Head and fostering a culture of excellence, collaboration, and innovation.

Role and Responsibilities

Provide credible scientific support to the activities of Global Regulatory Affairs Reaches agreement on scientific regulatory strategies with relevant teams, functions and management. Support of and sharing of relevant information with functions outside Global Regulatory Affairs Assess technologies under consideration by CSL Vifor from the scientific and regulatory perspectives. As responsible of scientific service, following DL219/06, guarantees a correct scientific communication in compliance with internal SOPs and external rules and laws, towards HCPs, patients and media. Ensure that local SOPs are aligned with Global ones and provide support to the definition of new Local SOPs as needed. Maintain updated SOPs. Coordinate quality activities along with the Local Quality Assurance Support (External) and relevant internal stakeholders. Develops and shapes regulatory strategies in collaboration with the relevant functions based on the profound knowledge scientific insights and principles. Supports the various Regulatory representatives to the GPT by giving scientific input. Builds up and maintains regulatory scientific network within the company, incl. support of the regulatory functions at Vifor Pharma sites and affiliates. Eensures that company's pharmaceutical advertising complies with the requirements of decree 219/06. Verifies that the scientific representatives employed by them have adequate training and comply with the obligations imposed by that decree. Provides AIFA with any information and assistance required for the exercise of its competences. Ensures that the measures adopted by the Ministry of Health and AIFA pursuant to that decree are respected immediately and fully. Keeps informed about key regulatory and scientific trends; provides input on potential impact to Vifor Pharma development plans and projects. Proactively addresses industry trends and opportunities and communicates to appropriate management functions. Works effectively in cross-functional teams

Educational Background and past experiences
• Advanced degree in science/medicine (MD, PhD, PharmD)
• 7+ years' pharmaceutical/ biotherapeutics industry experience
• Strong knowledge of regulations regarding drug promotion and dissemination of medical and product information within Italy
• Demonstrated leadership/management experience

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

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