Regulatory Affairs Specialist

3 settimane fa


Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

We're seeking a highly skilled Regulatory Affairs Scientist to join our team at Eli Lilly.

This role will be part of the CMC Regulatory team at our manufacturing site in Sesto Fiorentino, Italy, responsible for drug registration activities within the production facility and contract manufacturers.

Main responsibilities:

  • Provide regulatory support for products/contract manufacturers and projects as required, by preparing and maintaining the appropriate regulatory submission documentation needed to obtain/maintain Marketing Authorisation.
  • Lead the preparation, review, and finalization of CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.
  • Develop global CMC regulatory strategies in collaboration with other regulatory, MS&T, Quality, and project personnel to enable timely completion of submission milestones leading to health authority approval.
  • Ensure that Regulatory Tools are used and appropriately updated with accurate information and in a timely manner.
  • Ensure that all changes and deviations are reviewed and that any required regulatory activity carried out prior to implementation.
  • Identify and escalate CMC regulatory issues impacting product submissions across geographies.
  • Provide regulatory guidance to Global Post Launch Optimization Teams, Change Control Boards, and Technical forums, and implement regulatory strategies that result in successful product updates.
  • Ensure that all applicable GMP documents are in compliance with current regulatory commitments.
  • Review/Approve the Regulatory supporting documents.

Required qualifications:

  • Master's degree in a scientific field (CTF, Biology, Chemistry)
  • Excellent command of the English language
  • Demonstrated CMC Regulatory knowledge/experience, including EU/US and ICH guidelines
  • Excellent communication skills and ability to influence
  • Willingness to travel as requested
  • Appreciation of cultural diversity
  • Attention to detail.

Lilly is an equal opportunities employer and welcomes applications from all qualified candidates.



  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We are seeking a talented Regulatory Affairs Scientist to join our team at Eli Lilly. As a key member of the CMC Regulatory team, you will be responsible for drug registration activities within the production facility and contract manufacturers.Main responsibilities:Provide regulatory support for products/contract manufacturers and projects as required.Lead...


  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're seeking a talented Regulatory Affairs Scientist to join our team at Eli Lilly. As a key member of the CMC Regulatory team, you'll be responsible for drug registration activities within our production facility and contract manufacturers.Main responsibilities:Provide regulatory support for products/contract manufacturers and projects, preparing and...


  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're seeking a talented Regulatory Affairs Scientist to join our team at Eli Lilly.This role will be part of the CMC Regulatory team at our manufacturing site in Sesto Fiorentino, Italy, responsible for drug registration activities within the production facility and contract manufacturers.Main responsibilities:Provide regulatory support for...


  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We're looking for a talented Regulatory Affairs Scientist to join our team at Eli Lilly.This role will be part of the CMC Regulatory team at our manufacturing site in Sesto Fiorentino, Italy, responsible for drug registration activities within the production facility and contract manufacturers.Main responsibilities:Provide regulatory support for...


  • Sesto Fiorentino, Toscana, Italia Risorse SpA A tempo pieno

    Per Risorse SpA, azienda cliente attiva nel settore chimico, selezioniamo:Specialista affari regolatori - Regulatory affairsLa risorsa selezionata lavorerà a stretto contatto con il team di laboratorio e il responsabile della qualità e si occuperà di definire e mantenere la compliance normativa relativa alla commercializzazione internazionale dei prodotti...


  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    Job Title: Senior Sterility Assurance SpecialistWe are seeking a highly skilled and experienced Senior Sterility Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of sterility assurance in our parenteral manufacturing operations.Key...


  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    Job SummaryWe are seeking a highly skilled and experienced Senior Sterility Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance department, you will be responsible for providing technical leadership and oversight to ensure the highest standards of sterility assurance in our parenteral manufacturing operations.Key...


  • Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    Lilly is dedicated to addressing the challenges of cancer through innovative medicines and approaches.Main Responsibilities:The Oncology Sales Representative will play a key role in driving business growth and delivering value to customers in the Oncology space.Key Areas of Focus:Business Development: Identify and pursue new business opportunities, building...

  • Molecular Steward

    1 giorno fa


    Sesto Fiorentino, Toscana, Italia Lilly A tempo pieno

    We are seeking a highly skilled Molecular Steward to support the deployment of technical initiatives in the Parenteral Area of our Sesto Manufacturing Site.This role will involve coordinating specific activities, preparing documents, executing studies, and writing reports.Key Responsibilities and Activities:Ensure the accuracy of periodic reports on...


  • Sesto Fiorentino, Provincia di Firenze, Italia Risorse SpA A tempo pieno

    Per azienda cliente attiva nel settore chimico, selezioniamo: Addetto/a affari regolatori - Regulatory affairs La risorsa selezionata lavorerà a stretto contatto con il team di laboratorio e il responsabile della qualità e si occuperà di definire e mantenere la compliance normativ


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    We’re looking for people who are determined to make life better for people around the world. Eli Lilly is seeking a Regulatory Affairs Scientist . This role will be part of the CMC Regulatory team at the manufacturing site in Sesto Fiorentino (FI), responsible for drug registration activities within the production facility and contract manufacturers....


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Regulatory Affairs

    5 mesi fa


    Sesto Fiorentino, Italia CBS LAVORO A tempo pieno

    CBS Lavoro S.p.a. - employment agency - is searching for a **Regulatory Affairs & Quality Assurance Assistant** for a client company. **Tasks**: - You support the QA Department in managing the Quality Management System and the RA Department in maintaining regulatory compliance for quality, safety and environment - You maintain and update QMS...


  • Sesto Fiorentino, Italia Risorse SpA A tempo pieno

    Per azienda cliente attiva nel settore chimico, selezioniamo:Addetto/a affari regolatori - Regulatory affairsLa risorsa selezionata lavorerà a stretto contatto con il team di laboratorio e il responsabile della qualità e si occuperà di definire e mantenere la compliance normativa relativa alla commercializzazione internazionale dei prodotti dell'azienda.I...


  • Sesto Fiorentino (FI), Italia Risorse SpA A tempo pieno

    Per azienda cliente attiva nel settore chimico, selezioniamo: Addetto/a affari regolatori - Regulatory affairs La risorsa selezionata lavorerà a stretto contatto con il team di laboratorio e il responsabile della qualità e si occuperà di definire e mantenere la compliance normativa relativa alla commercializzazione internazionale dei prodotti...


  • Sesto Fiorentino (FI), Italia Risorse spa A tempo pieno

    Autore annuncio: Risorse spa Zona lavoro: Sesto Fiorentino, Firenze Data pubblicazione: 08 novembre 2024 Sigla riferimento: 20926/11 Descrizione offerta: Luogo di lavoro: Sesto Fiorentino Descrizione azienda Per azienda cliente attiva nel settore chimico, selezioniamo: Posizione Addetto/a affari regolatori - Regulatory affairs La risorsa selezionata...


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Sesto San Giovanni, Italia Risorse Spa A tempo pieno

    Risorse Professional , realtà specializzata nella Ricerca e Selezione di profili di middle e top management, per prestigiosa SGR operativa nella gestione di Fondi chiusi, ricerca: Legal Corporate Affairs Specialist La figura ricercata sarà inserita all'interno dell'area Corporate & Legal Affairs, riportando gerarchicamente al General Counsel.Le principali...


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Sr. Associate

    4 mesi fa


    Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Sesto San Giovanni, Lombardia, Italia ABB Schweiz AG A tempo pieno

    Main Responsibilities:The selected candidate will oversee the management of administrative documentation to ensure seamless participation in public and private tenders, customer qualification activities, and employee access to customer sites. As a key regulatory and fiscal reference for the local organization, the individual will provide essential support...


  • Sesto Fiorentino, Italia Lilly A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...


  • Sesto San Giovanni, Italia ManpowerGroup A tempo pieno

    Manpower Professional ricerca un/a Infrastructure Operational Excellence (OpEx) SpecialistThe infrastructure operational excellence specialist is responsible to support thedevelopment, management, and implementation of process and systems which enablethe effective operation of the GRA, GPV and GCO unit within Italfarmaco.The individual will act as system...


  • Sesto San Giovanni, Italia Heineken A tempo pieno

    **CHI SIAMO** HEINEKEN è presente in Italia dal 1974 con l’acquisizione di Birra Dreher e del birrificio di Massafra. Nel 1986 inizia la crescita dell’azienda grazie all’acquisizione di Birra Ichnusa Spa, birrificio di Assemini in provincia di Cagliari. Nel 1989 HEINEKEN costituisce Partesa, società specializzata nei servizi di vendita,...

  • EHS Specialist

    5 mesi fa


    Sesto San Giovanni, Italia GE Renewable Energy A tempo pieno

    **Job Description Summary**: The EHS Specialist will act as a member of the EHS Team in Sesto San Giovani Site and be the EHS focal point for the assigned area and/or process. The mission will be to develop, plan and execute the Environmental Health and Safety programs and policies. **Essential Responsibilities** - Support the EHS Team to define, improve,...


  • Sesto San Giovanni, Lombardia, Italia Abb Schweiz Ag A tempo pieno

    Job SummaryA challenging role has become available in our team for a skilled HSE & Subcontract Documentation Specialist. As a key member of our organization, you will be responsible for managing administrative documentation to guarantee tender participation to public and private companies, customer qualification activities, and employees' access to customer...

  • EHS Specialist

    5 mesi fa


    Sesto San Giovanni, Italia Renewable Energy Grid Solutions A tempo pieno

    **Job Description Summary**: The EHS Specialist will act as a member of the EHS Team and will be based in the Sesto San Giovani Site. The mission will be to develop, plan and execute the Environmental Health and Safety programs and policies. We are looking for an apprenticeship of 24 month. **Job Description**: Essential Responsibilities - Support the EHS...