Senior Regulatory Affairs

1 settimana fa

Lazio, Italia Confidenziale A tempo pieno

Categoria:
Healthcare / PharmaceuticalLuogo di lavoro:
Lodi e provinciaFor our client company
Main responsibilitiesEnsure that the organization is operating in compliance with regulatory requirements and industry guidelines, including the review of applicable quality assurance policies, QMS documents and global regulatory guidance to ensure alignment with regulatory requirements and harmonization with QA policies of clients, other recognized institutions and Regulatory Agencies.Ensure the preparation and maintenance of regulatory submissions and files worldwide.Conducting regulatory communications with FDA, under appropriate supervision and direction, for assigned products and activitiesManage electronic submissions in eCTD formatMaintain and improve working knowledge of current/pending regulations and guidance for generic drugs and new drugs to ensure compliance with Regulatory Agency requirementsLead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory agenciesBuild and maintain client relationships on regulatory matters with appropriate internal and external stakeholders.Provide technical assistance and consultationon regulatory matters to all the company units, as requestedContribute to the company business development efforts as requested.Requisiti:
QUALIFICATIONS Professional and Technical Knowledge

experience with API registration, authorization and certification requirements.
Knowledge of pharmaceutical and regulatory requirements for international markets such as but not limited to United States and European Union
Experience with pharmaceutical product dossier compilation and review.
Experience in pharmaceutical laboratory commodities, tests, equipment, and techniques.
Knowledge of FDA, WHO, in-country regulations, and stringent regulatory authorities with previous Good Manufacturing Practice (GMP) inspection experience.
Advanced computing skills in standard software systems, such as Microsoft Office suite.
Strong interpersonal skills and an ability to work across disciplines and in diverse locations internationally.
Excellent written and oral communication skills. English fluency required, additional international business language fluency is preferable.
Salary commensurate with experience.The Senior Regulatory Expert can devolop a career as a Regulatory Manager.

  • Senior Regulatory Manager

    1 settimana fa

    Lazio, 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.

  • Regulatory Affairs Analyst

    4 giorni fa

    Lazio, Italia Confidenziale A tempo pieno

    Settore: Farmaceutica e biotecnologiaLuogo di lavoro: Roma - RomaFILIALE: ROMA OFFICE SPECIALIZZAZIONE: LS01 Our client, a global biopharmaceutical company, is searching for a REGULATORY AFFAIRS ANALYST KEY RESPONSIBILITIES: - Support Regulatory Office in maintaining marketing authorizations for existing pharmaceutical products - Liaise with European...

  • Junior Regulatory Affairs Specialist

    2 settimane fa

    Lazio, 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...

  • Visa Cash App Rb Formula 1 Team

    2 settimane fa

    Lazio, Italia Red Bull Gruppe A tempo pieno

    Step into the thrilling world of Formula 1 with Visa Cash App RB F1 Team, and don't miss your unique opportunity to make a meaningful impact in a dynamic and innovative environment.We are one of the two Red Bull-owned Formula 1 Teams, and a group of passionate professionals always striving for excellence and continuous improvement in every aspect of our...

  • Regulatory Advisor

    2 settimane fa

    Lazio, 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 2 Days Ago job requisition id 4910351 Pfizer is hiring an enthusiastic Regulatory Affairs Advisor for the Global Regulatory Strategy (GRS) -...

  • Regulatory Advisor

    6 giorni fa

    Lazio, 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) -...

  • Humanitarian Affairs Officer/Internal Displacement Adviser, P4

    6 giorni fa

    Lazio, Italia United Nations A tempo pieno

    Job Opening Job Opening ID: 232542 Job Network : Political, Peace and Humanitarian Job Family : Humanitarian Affairs Category and Level : Professional and Higher Categories , P-4 Department/Office : Office for the Coordination of Humanitarian Affairs This position is located in the Internal Displacement Unit, Office of the Under-Secretary General...

  • Humanitarian Affairs Officer/Internal Displacement Adviser, P4

    6 giorni fa

    Lazio, Italia United Nations A tempo pieno

    Job OpeningJob Opening ID :232542Job Network:Political, Peace and HumanitarianJob Family:Humanitarian AffairsCategory and Level:Professional and Higher Categories,P-4Department/Office:Office for the Coordination of Humanitarian AffairsThis position is located in the Internal Displacement Unit, Office of the Under-Secretary General for Humanitarian Affairs...

  • Responsabile Ufficio Affari del Regolatorio con

    5 giorni fa

    Lazio, Italia Confidenziale A tempo pieno

    , Business Unit di Roma, cerca per cliente in forte crescita che opera nella produzione e commercializzazione di dispositivi medicali un/a RESPONSABILE AFFARI REGOLATORI - REGULATORY AFFAIRS MANAGER con esperienza pregressa La persona, all'interno di un team già consolidato composto da 4 persone e riportando al Direttore Tecnico, si occuperà...

  • Bausch & Lomb Gmbh: Job in Germany (Heidelberg):

    2 settimane fa

    Lazio, Italia Confidenziale A tempo pieno

    Bausch + Lomb is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. As a part of the Bausch Health Group the company is one of the best-known and most respected healthcare brands...

  • Regulatory & Competition Expert

    2 settimane fa

    Lazio, Italia Iliad Italia S.P.A. A tempo pieno

    Nel 2018 siamo arrivati in Italia con l'obiettivo di rivoluzionare il mercato delle telecomunicazioni e la vita di milioni di utenti. Per farlo, abbiamo messo al centro le persone costruendo relazioni basate su trasparenza e fiducia e promuovendo innovazione, semplicità e qualità. In 5 anni abbiamo superato i 10 milioni di utenti, sviluppato una rete...

  • Regulatory Affairs Expert

    3 giorni fa

    Lazio, Italia Confidenziale A tempo pieno

    Randstad Talent Selection è la divisione di Randstad Italia focalizzata sulla ricerca&selezione di profili professionali qualificati e altamente specializzati,ricerchiamo per primaria azienda cliente operante nel settore chimico farmaceutico la figura di Addetto affari regolatori.Si offre contratto diretto a tempo indeterminato e RAL commisurata...

  • Gvp Auditor

    1 settimana fa

    Lazio, Italia Arithmostech A tempo pieno

    We are experts in the Life Sciences industry & Technology.We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.Job...

  • Gvp Auditor

    2 settimane fa

    Lazio, Italia Arithmostech A tempo pieno

    We are experts in the Life Sciences industry & Technology.We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.Job...

  • Senior Project Development Manager

    2 settimane fa

    Lazio, Italia Leap29 A tempo pieno

    Senior Project Development ManagerLeap29 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...

  • Senior Manager

    4 giorni fa

    Lazio, Italia Confidenziale A tempo pieno

    Categoria: Financial ServicesLuogo di lavoro: Milano e provinciaContesto dinamico e sfidanteOttima opportunità di carriera La risorsa sarà coinvolta in progettualità legate all'analisi e al processo di produzione del Supervisory Reporting e avrà principalmente le seguenti responsabilità: Gestione di progettualità complesse in ambito regulatory...

  • Stage Affari Regolatori

    6 giorni fa

    Lazio, Italia Confidenziale A tempo pieno

    Ricerchiamo per uno stabilimento farmaceutico di L'Aquila una persona da inserire in STAGE nell'area Quality Operation, settore Regulatory Affairs. Si intende far acquisire alla persona in tirocinio competenze in ambito di qualità con particolare riferimento al settore Regolatorio. Le attività in affiancamento previste sono: - Controllo della...

  • Onstage Internship Program Legal

    7 giorni fa

    Provincia di Roma, Lazio, Italia Wind Tre S.p.A. con Socio Unico A tempo pieno

    OnStage Internship Program LEGAL & PRIVACY **Roma, Lazio**: Sei un/una brillante laureato/a o laureando/a in area giuridica? Hai voglia di crescere con noi? Candidati per il nostro OnStage Internship Program! Il team Siamo alla ricerca di una persona che voglia fare un’esperienza professionalmente ricca e formativa in un ambiente dinamico e...

  • Senior Analytics Consultant

    2 settimane fa

    Lazio, Italia Experian A tempo pieno

    We are looking to hire a brilliant Senior Analytics Consultant to join our diverse team at Experian in Roma. Growing your career as a Full Time Senior Analytics Consultant is an amazing opportunity to develop vital skills. If you are strong in research, strategic planning and have the right determination for the job, then apply for the position of Senior...

  • Quality Manager Railway Sector

    2 settimane fa

    Lazio, 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...