Senior Regulatory Manager

Trovato in: Jooble IT O C2 - 2 settimane fa

Roma, Italia CSL Vifor 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.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor

  • Regulatory Affairs Manager

    2 settimane fa

    Roma, Italia Ergomed A tempo pieno

    Company Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...

  • Junior Regulatory Affairs Specialist

    Trovato in: Jooble IT O C2 - 3 giorni fa

    Roma, Italia ADECCO ITALIA S.p.A. A tempo pieno

    Adecco italia Spa is looking for an important client in the pharmaceutical sector a JUNIOR REGULATORY AFFAIRS SPECIALIST Basic Functions & Responsibility (may not be limited to) Be responsible for the management of the authorized products through timely submission of variations, application renewals and supplemental marketing authorizations.Carry out...

  • Senior Project Development Manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia Leap29 A tempo pieno

    Senior Project Development Manager Leap29 are currently assisting a leading, international Renewable Energy company who are hiring for a Senior Project Development Manager to join their team in Rome. We are searching for a candidate who will be responsible for managing all aspects of the development of utility scale solar projects. You will manage...

  • Regulatory Advisor

    Trovato in: Jooble IT O C2 - 1 settimana fa

    Roma, Italia Pfizer A tempo pieno

    Regulatory Advisor - maternity leave replacement page is loaded Regulatory Advisor - maternity leave replacement Apply locations Italy - Rome Italy - Catania Italy - Ascoli Piceno time type Full time posted on Posted 8 Days Ago job requisition id 4910351 Pfizer is hiring an enthusiastic Regulatory Affairs Advisor for the Global Regulatory Strategy (GRS) -...

  • Senior Cost Manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia Illinois Employer A tempo pieno

    This job was posted by : For moreinformation, please see: Senior Cost Manager (Franklin Park, IL): Actively participate & analyzetenders/bids to ensure client value for money. Create estimates & costplans. Reqs: Bachelors degree in Quantity Surveying/ConstructionMgmt./foreign equiv. + 12 mths exp in Position/QuantitySurveyor/Estimator Mail CV to Linesight,...

  • Euronext Clearing

    Trovato in: Jooble IT O C2 - 3 giorni fa

    Roma, Italia Euronext A tempo pieno

    Euronext Clearing - Senior Risk Manager page is loaded Euronext Clearing - Senior Risk Manager Apply locations Rome - via Tomacelli Milan time type Full time posted on Posted 30+ Days Ago job requisition id R14080 Euronext Clearing, the Euronext's Central Counterparty in Italy is a multi-asset clearing house that provides proven risk management capabilities...

  • Senior Project Manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia Solido Hotel A tempo pieno

    Registrati per visualizzare i contatti dell'azienda Effettua il login per ricevere email con offerte simili Per ampliamento delle nostre strutture alberghiere ricerchiamo un Senior Project Manager da inserire all’interno della nostro struttura. Si richiede pregressa esperienza nella gestione dei cantieri alberghieri di lusso. Disponibilità...

  • Senior Account manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia dm3 A tempo pieno

    Ricerchiamo per stage copywriter pubblicitario, advertising, materiale istituzionale, redazionali, Richiesta passione e creatività. Collaborazione: Senior Account manager Ricerchiamo Account Manager neolaureati e/o con esperienza per attività di ricerca new business e gestione di progetti di comunicazione: grafica, immagine, strategic design, web design,...

  • Project Manager

    2 giorni fa

    Roma, Italia IQVIA A tempo pieno

    **Junior Programme Manager** - Support Programmes to Clinical Centres and Patients_ Italy Team Our mission is to design and develop innovative solutions with the objective of enhancing the quality of care to Patients, optimise investments, maximise effectiveness and resource utilisation. We strive to offer excellent service to Patients and their...

  • Senior Account manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia dm3 A tempo pieno

    Ricerchiamo per stage copywriter pubblicitario, advertising, materiale istituzionale, redazionali, Richiesta passione e creatività. Collaborazione: Senior Account manager Ricerchiamo Account Manager neolaureati e/o con esperienza per attività di ricerca new business e gestione di progetti di comunicazione: grafica, immagine, strategic design, web...

  • ICT Service Manager Senior

    Trovato in: Jooble IT O C2 - 3 giorni fa

    Roma, Italia Herzum Software S.R.L. Unipersonale A tempo pieno

    Per un nostro Partner, siamo alla ricerca di un profilo "ICT Service Manager Senior". Il candidato sarà inserito nel gruppo di Service Management per la gestione di clienti Corporate. Sede di lavoro: full remote. Sono previsti sporadici incontri in sede a Milano (1 o 2 volte al mese) . Competenze in ambito IT Sistemi Rete (accesso e...

  • Senior Product Manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia Iglu.com A tempo pieno

    I started my journey with our Planet Cruise brand in 2009 as a customer service executive. Since then I have worked within our marketing department, seen the company grow as we merged with Iglu, completed an undergraduate degree and finally, moved into the product and commercial team where I'm a Senior Product Manager with a team of 2 others. Between us we...

  • Senior Operation Manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia Michael Page International Italia S.r.l. A tempo pieno

    Azienda Il nostro Partner in questo progetto di ricerca è un'Azienda organizzatrice di Tour guidati sia in Italia che all'estero. In ottica di ulteriore stutturazione dell'organico si valuta l'inserimento di un/una Senior Operations Manager. Sede: Roma/ possibilità di Smart Working. Job Description Role mission Improve guided tour experiences across...

  • Euronext Clearing

    Trovato in: Talent IT C2 - 3 settimane fa

    Roma, Italia Euronext A tempo pieno

    Euronext Clearing, the Euronext's Central Counterparty in Italy is a multi-asset clearing house that provides proven risk management capabilities on 14 markets, across a range of trading venues including Euronext Milan, MTS, BrokerTec and Hi-mtf. Asset classes cleared include equities, ETFs, Closed-end Funds, Financial Derivatives, Commodities (Agricultural...

  • Senior Clinical Operations Manager

    Trovato in: beBee S IT - 4 settimane fa

    Roma, Italia MSD A tempo pieno

    Job DescriptionThis role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company's policies and procedures and with quality standards internally and externally.The person has ownership, oversight, and impact on local regulatory and financial compliance and...

  • Senior Operation Manager

    Trovato in: Jooble IT O C2 - 5 ore fa

    Roma, Italia Michael Page A tempo pieno

    Azienda organizzatrice di Tour guidati Sede: Roma Il nostro clienteIl nostro Partner in questo progetto di ricerca è un'Azienda organizzatrice di Tour guidati sia in Italia che all'estero. In ottica di ulteriore stutturazione dell'organico si valuta l'inserimento di un/una Senior Operations Manager. Sede: Roma/ possibilità di Smart...

  • Senior Operation Manager

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia Michael Page International Italia S.r.l. A tempo pieno

    Azienda Il nostro Partner in questo progetto di ricerca è un'Azienda organizzatrice di Tour guidati sia in Italia che all'estero. In ottica di ulteriore stutturazione dell'organico si valuta l'inserimento di un/una Senior Operations Manager. Sede: Roma/ possibilità di Smart Working. Job Description Role mission Improve guided tour...

  • Quality Manager Railway Sector

    Trovato in: Jooble IT O C2 - 2 settimane fa

    Roma, Italia ADECCO ITALIA S.p.A. A tempo pieno

    Adecco Roma Financial Services researches, for a Leader Company of the luxury hospitality and lifestyle sector, a Quality Manager Railway Sector Key Responsibilities: · Quality Assurance Program Management: Develop, implement, and maintain a robust quality assurance program for railway operations and maintenance. Define quality standards and procedures to...

  • Senior Risk Manager, Product Safety And Compliance

    5 giorni fa

    Roma, Italia Amazon Europe Core A tempo pieno

    Role available in Luxembourg, Munich and Milan. We are seeking a experienced Senior Risk Manager, to lead and develop a team of program managers responsible for risk policy and governance initiatives in the Europe and UK. The ideal candidate will possess strong leadership and people management skills, with the ability to set strategic direction and drive...

  • Senior CRA

    Trovato in: Jooble IT O C2 - 3 giorni fa

    Roma, Italia Barrington James Limited A tempo pieno

    Barrington James is actively recruiting for a challenging role as a Clinical Research Associate (CRA II). As part of our clients in-house team, you will be responsible for site management, encompassing start-up activities both on-site and remotely across Italy. This role involves working on diverse projects from our client base, which includes small to...