Regulatory Affairs Specialist
4 settimane fa
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 the preparation, review, and finalization of CMC documents for global regulatory submissions.
- Develop global CMC regulatory strategies in collaboration with other regulatory, MS&T, Quality, and project personnel.
- Ensure that all changes and deviations are reviewed and that any required regulatory activity is 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.
- Ensure that all applicable GMP documents are in compliance with current regulatory commitments.
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.
-
Regulatory Affairs Specialist
4 settimane fa
Sesto Fiorentino, Toscana, Italia Lilly A tempo pienoWe'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...
-
Regulatory Affairs Specialist
4 settimane fa
Sesto Fiorentino, Toscana, Italia Lilly A tempo pienoWe'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...
-
Specialista affari regolatori
3 settimane fa
Sesto Fiorentino, Toscana, Italia Risorse SpA A tempo pienoPer 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...
-
Aseptic Process Specialist
6 giorni fa
Sesto Fiorentino, Toscana, Italia Lilly A tempo pienoLilly, a global healthcare leader, is seeking an experienced Aseptic Process Specialist to join their Sterility Assurance Team. This role is responsible for coordinating the primary loop agenda, resolving issues on the field, and maintaining connections between primary and secondary loops.Job Description:The successful candidate will ensure sustainable...
-
Drug Product Manufacturing Quality Assurance Specialist
2 settimane fa
Sesto Fiorentino, Toscana, Italia Lilly A tempo pienoLilly is a global healthcare leader headquartered in Indianapolis, Indiana. As a leading innovator in the pharmaceutical industry, we're dedicated to discovering and bringing life-changing medicines to those who need them.We're currently seeking a Drug Product Manufacturing Quality Assurance Specialist to join our team in ensuring the highest quality...
-
Oncology Business Development Specialist
2 settimane fa
Sesto Fiorentino, Toscana, Italia Lilly A tempo pienoLilly 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
2 settimane fa
Sesto Fiorentino, Toscana, Italia Lilly A tempo pienoWe 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...
-
Global Diabetes Sales Professional
2 settimane fa
Sesto Fiorentino, Toscana, Italia Eli Lilly and Company A tempo pienoAbout Eli Lilly and CompanyEli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. We unite caring with discovery to create medicines that make a real difference in the lives of people.About the RoleWe are seeking a highly motivated and experienced Sales Representative to join our team in the Toscana...
-
Addetto/a affari regolatori
3 settimane fa
Sesto Fiorentino, Provincia di Firenze, Italia Risorse SpA A tempo pienoPer 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
-
Regulatory Affairs Scientist
6 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoWe’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....
-
Regulatory Affairs Scientist
7 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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 pienoCBS 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...
-
Addetto/a affari regolatori
3 settimane fa
Sesto Fiorentino, Italia Risorse SpA A tempo pienoPer 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...
-
Addetto/a affari regolatori
3 settimane fa
Sesto Fiorentino (FI), Italia Risorse SpA A tempo pienoPer 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...
-
Addetto/a affari regolatori
2 settimane fa
Sesto Fiorentino (FI), Italia Risorse spa A tempo pienoAutore 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...
-
Addetto/a affari regolatori
2 settimane fa
Sesto Fiorentino (FI), Italia Risorse spa A tempo pienoAutore 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...
-
Associate - Medical Affairs Professional
5 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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...
-
Diabetes Medical Affairs Professional
2 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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...
-
Legal Corporate Affairs Specialist
1 mese fa
Sesto San Giovanni, Italia Risorse Spa A tempo pienoRisorse 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...
-
Associate - Medical Affairs Oncology
6 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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...
-
Real World Evidence
6 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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
5 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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 Documentation Specialist
2 settimane fa
Sesto San Giovanni, Lombardia, Italia ABB Schweiz AG A tempo pienoMain 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...
-
Crs Gastroenterology
6 mesi fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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...
-
Corporate Affairs Specialist
5 mesi fa
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 pienoJob 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...
-
Parenteral Process Engineer
7 giorni fa
Sesto Fiorentino, Italia Lilly A tempo pienoAt 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...