Regulatory Affairs Consultant

7 giorni fa

Firenze, Italia JSB SOLUTIONS S.R.L A tempo pieno

**JSB Solutions**, società di servizi nel settore Life Science che offre consulenza, gestione di studi clinici e sviluppo software, con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un
**Regulatory Affairs Consultant**:

- (JSB.SRF.23.064)_ da inserire all'interno della nostra divisione degli
**affari regolatori**.

**Junior Regulatory Affairs**
**di almeno 1 anno,** maturata in aziende farmaceutiche.
- predisposizione della necessaria documentazione per la registrazione EU&Extra-EU (preparazione/assemblaggio dossier del farmaco);
- predisposizione della necessaria documentazione per i rinnovi EU&Extra-EU;
- preparazione pacchetti regolatori per variazioni EU&Extra-EU;
- supporto alle filiali italiane per il regolatorio amministrativo (AIFA front-end, POL, Convegni e congressi);
- eCTD e RiMS;
- regulatory Compliance e valutazione regolatoria Change Control.

**Requisiti richiesti dal ruolo**:

- conoscenza delle linee guida ICH, AIFA, EU e delle normative e direttive internazionali;
- conoscenza approfondita delle norme GMP;
- ottima conoscenza della lingua inglese (scritto e parlato);
- disponibilità a trasferte su territorio nazionale;
- spiccate doti comunicative e relazionali;
- attitudine al problem solving.

**Modalità di lavoro**:formula mista Ufficio - Smart Working

  • Euna Regulatory Affairs Specialist

    3 giorni fa

    Firenze, Italia Menarini Group A tempo pieno

    Overview: Within the Global Regulatory Affairs department - EU and North America area (EUNA), Menarini Ricerche Spa is looking for a Regulatory Affairs Specialist with a direct report to the EUNA Therapeutic Area Manager. The resource will be responsible of handling a specific portfolio of products, guaranteeing the obtainment of new registrations and/or...

  • Latam Regulatory Affairs Coordinator | Global Market Access

    2 settimane fa

    Firenze, Italia Manpowergroup A tempo pieno

    A leading global staffing and workforce solutions company is seeking a Regulatory Affairs Central and Latin America Coordinator in Florence.This role requires a Master's degree and at least 5 years of experience in regulatory affairs, focusing on Central and South America.The successful candidate will plan product registrations, ensure compliance, and...

  • LATAM Regulatory Affairs Coordinator | Global Market Access

    2 settimane fa

    Firenze, Italia ManpowerGroup A tempo pieno

    A leading global staffing and workforce solutions company is seeking a Regulatory Affairs Central and Latin America Coordinator in Florence. This role requires a Master's degree and at least 5 years of experience in regulatory affairs, focusing on Central and South America. The successful candidate will plan product registrations, ensure compliance, and...

  • Regulatory Affairs Administration Assistant_legge 68/99

    2 settimane fa

    Firenze, Italia Randstad Italia Spa A tempo pieno

    Mansione Randstad Talent Selection Hopportunities è la specialty che si occupa di Ricerca &, Selezione di professionisti qualificati appartenenti alle categorie protette. Il nostro cliente è un'importante realt internazionale e ci ha incaricato di ricercare la figura di Regulatory Affairs Administration Assistant_ legge 68/99 (invalidit civile) Si offre...

  • Global Regulatory Affairs Operations

    5 giorni fa

    Firenze, Italia Menarini Group A tempo pieno

    Overview: We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Operations Specialist to join our Content Management team. In this role, the hired person will be instrumental in supporting the Content Management Manager and ensuring the successful implementation and management of Veeva RIM solution. The hired person will provide...

  • Regulatory Affairs Coordinator Central And Latin America

    2 settimane fa

    Firenze, Italia Manpowergroup A tempo pieno

    Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for aRegulatory Affairs Central and Latin America CoordinatorAre you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale?Do you thrive in a fast-paced environment where...

  • Regulatory Affairs Coordinator Central and Latin America

    2 settimane fa

    Firenze, Italia ManpowerGroup A tempo pieno

    Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for a Regulatory Affairs Central and Latin America Coordinator Are you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale? Do you thrive in a fast-paced environment...

  • Regulatory Affairs Coordinator Central and Latin America

    6 giorni fa

    firenze, Italia ManpowerGroup A tempo pieno

    Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for aRegulatory Affairs Central and Latin America CoordinatorAre you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale? Do you thrive in a fast-paced environment where...

  • Regulatory Affairs Coordinator Central and Latin America

    3 settimane fa

    Firenze, Toscana, Italia Manpower A tempo pieno

    Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for a Regulatory Affairs Central and Latin America Coordinator Are you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale? Do you thrive in a fast-paced environment...

  • Regulatory Affair Lead

    3 giorni fa

    Firenze, Italia Quest Global A tempo pieno

    **Job Requirements** - Regulatory Compliance: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 and other global standards. - ** Analyze the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.**: - **...