Lavori attuali relativi a Cmc Regulatory Affairs Manager - Lombardia - Buscojobs
-
Senior Regulatory Affairs Manager
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve. We are looking for a Senior Regulatory Affairs Manager / Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in...
-
Principal Regulatory Affairs Consultant
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve. Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory...
-
Regulatory Affairs Head
4 settimane fa
Lombardia, Italia Pharma Point Srl A tempo pienoWe are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head Key Responsibilities: Lead and manage the Regulatory Affairs team, ensuring proper training and professional development. Supervise the preparation, updates, and submission of European and international regulatory dossiers. ...
-
Regulatory Affairs Head
7 giorni fa
Lombardia, Italia Buscojobs A tempo pieno5 giorni fa We are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head. Key Responsibilities: Lead and manage the Regulatory Affairs team, ensuring proper training and professional development. Supervise the preparation, updates, and submission of European and international...
-
Regional Director, Regulatory Affairs
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve. We are seeking a highly skilled and experienced Regional Regulatory Affairs Director (EMEA) to join our team. As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to...
-
Regulatory Cmc Specialist
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoDescrizione del lavoro Eurofins Regulatory and Consultancy Services Italy è alla ricerca di un Regulatory CMC Specialist con esperienza, autonomo e con una solida conoscenza del settore. La risorsa sarà responsabile di supportare e guidare i clienti nella gestione dei requisiti di Chemistry, Manufacturing and Controls (CMC) per lo sviluppo e la...
-
Regional Director, Regulatory Affairs
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve. We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to Managers and...
-
Senior Regulatory Affairs Consultant
1 mese fa
Lombardia, Italia Buscojobs A tempo pienoSenior Regulatory Affairs Consultant – MAAs Global Acceleration Initiative Parexel When our values align, there's no limit to what we can achieve. We are seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets. This is an exciting opportunity to...
-
CORPORATE REGULATORY AFFAIRS SPECIALIST
2 mesi fa
Lombardia, Italia Flamma spa A tempo pienoFlamma Group è un'azienda specializzata nello sviluppo, produzione e commercializzazione di molecole e principi attivi (API) per l'industria farmaceutica. Con Headquarter a Chignolo d'Isola, vicino a Milano, Flamma vanta altri due stabilimenti produttivi in Italia, ad Isso (BG) e Bulciago (LC) e due stabilimenti all'estero, a Philadelphia (USA) e Dalian...
-
Lombardia, Italia Ganassini Corporate A tempo pienoIl gruppo Ganassini cerca un/a Medical Device Regulatory Affairs Specialist . La persona si occuperà di supportare il Regulatory Affairs Manager e la Direzione Tecnica in tutte le attività regolatorie sui dispositivi medici a base di sostanze. Dovrà essere in grado di gestire autonomamente la preparazione dei fascicoli tecnici dei prodotti. Obiettivi...
-
Regulatory Affairs Specialist
7 mesi fa
Provincia di Milano, Lombardia, Italia Instrumentation Laboratory spa A tempo pienoFor our Clinical Chemistry Strategic Business Unit, based in Milan (Italy), we are looking for a: **Regulatory Affairs Specialist - Maternity Leave**: The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market. The main accountabilities of the Regulatory Affairs Specialist are: Support registrations, understand the local...
-
Cosmetic Regulatory Affairs Specialist
7 mesi fa
Provincia di Milano, Lombardia, Italia Ganassini Corporate A tempo pienoIl gruppo Ganassini cerca un/a Cosmetic Regulatory Affairs Specialist La risorsa inserita lavorerà a stretto contatto con Cosmetic Regulatory Affair Manager, occupandosi principalmente di: redigere Product Information File (PIF); collaborare con fornitori per la raccolta di documentazione relativa a materie prime e packaging; verificare che ogni prodotto...
-
Provincia di Milano, Lombardia, Italia Ganassini Corporate A tempo pienoIl gruppo Ganassini cerca un/a Medical Device Regulatory Affairs Specialist La persona si occuperà di supportare il Regulatory Affairs Manager e la Direzione Tecnica in tutte le attività regolatorie sui dispositivi medici a base di sostanze.Dovrà essere in grado di gestire autonomamente la preparazione dei fascicoli tecnici dei prodotti. **Obiettivi...
-
Cosmetic Regulatory Affairs Specialist
6 mesi fa
Provincia di Milano, Lombardia, Italia Ganassini Corporate A tempo pienoIl gruppo Ganassini cerca un/a Cosmetic Regulatory Affairs Specialist - Testing La risorsa inserita lavorerà a stretto contatto con Cosmetic Regulatory Affair Manager, occupandosi principalmente di: Definizione di protocolli sperimentali di efficacia e sicurezza adottati per effettuare test su prodotti cosmetici. Analisi statistica dei dati ottenuti...
-
Regulatory Affairs Specialist
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoMilano Descrizione del lavoro: Il/la candidato/a farà parte della divisione Regulatory Affairs di una nota realtà chimico-farmaceutica nostra cliente. Responsabilità: Gestione dei processi regolatori per la registrazione di Dispositivi Medici (MDR-Regolamento EU 2017/745 e linee guida MDCG correlate; ISO 13485; ISO 14971; ISO 14155; ISO 10993) nel...
-
Provincia di Milano, Lombardia, Italia GXPeople A tempo pieno: Quality Assurance **Posizione: Regulatory Affairs & Clinical Specialist** **Location: Milano provincia (on-site)** **Retribuzione: commisurata all'effettiva esperienza** Siamo alla ricerca di un Regulatory Affairs & Clinical Specialist per conto di un'azienda storica, basata in provincia di Milano. Si tratta di un'azienda fabbricante di Medical...
-
Medical Devices Regulatory Affairs Specialist
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoSolo per membri registrati Milano Descrizione del lavoro Per un’importante e riconosciuta Realtà Internazionale che opera nel campo Dermocosmesi, Dispositivi Medici ed Integratori e che fonda l’eccellenza dei suoi prodotti su ricerca, tecnologia e qualità, siamo alla ricerca di un/una Posizione: La persona si occuperà di supportare il Regulatory...
-
Regulatory Affairs Specialist- Innovative Products
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoNonStop Pharma ricerca un Regulatory Affairs Specialist per un’importante realtà cliente, produttore conto terzi e titolare di prodotti farmaceutici, in forte espansione. La figura si unirà a un team dinamico e in espansione, dove avrà un ruolo chiave nella gestione della conformità regolatoria e nell’elaborazione dei vari moduli del Dossier. ...
-
Sr Medical Affairs Manager Italy
7 giorni fa
Lombardia, Italia Buscojobs A tempo pienoThe Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: to forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just...
-
Regulatory Affairs Assistant
4 settimane fa
Lombardia, Italia Buscojobs A tempo pienoPosizione riservata alle categorie protette ai sensi di Legge 68/99 Opportunità lavorativa su Opera (MI) Il nostro cliente: Per industria chimica multinazionale e leader del proprio settore, con plant ad Opera (MI), stiamo selezionando un/a Regulatory And Quality Assurance Assistant appartenenti alle Categorie Protette. Ruolo: Le principali...
Cmc Regulatory Affairs Manager
1 mese fa
Fondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases.
For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to us.
Fondazione Telethon ETS is currently searching for a CMC Regulatory Affairs Manager.
The candidate will work in the Research and Development Department on specific Telethon’s projects in late development / marketing phase (Strimvelis, Telethon003) as well as Telethon’s Institutes’ (TIGET and TIGEM) projects in early / mid development phase.
The candidate will have the following responsibilities:
- Support the CMC Regulatory Team: Help the team implement and manage CMC regulatory strategies for gene therapy projects, ensuring everything aligns with regulatory requirements.
- Contribute to the regulatory strategy for clinical trials and commercial products by preparing CMC sections of regulatory dossiers, performing gap analyses, and helping address any missing information.
- Assist with Regulatory Authorities Inspections: Provide support during Regulatory Authorities inspections by ensuring that all necessary CMC regulatory information for investigational and commercial products is organized and compliant.
- Support in the preparation and documentation of regulatory submissions: Assist in preparing and managing CMC aspects of regulatory documents for assigned projects, including managing CMC-related requests for Orphan Drug Designation (ODD), Scientific Advice, and Pediatric Investigation Plans (PIP).
- Contribute to initial regulatory submissions for clinical trials and commercial products, and support the regulatory process throughout the product lifecycle, including submissions for changes to marketing authorizations (MAA / BLA) and investigational product dossiers (IMPD / IND).
- Monitor Regulatory framework: Stay on top of regulatory updates and contribute to the team’s strategy to ensure we always meet the latest standards, especially for orphan drugs, advanced therapies (ATMP), GMP, and compliance.
- Collaborate with CMC and Quality Assurance Teams: Ensure compliance of GMP documents to regulatory commitments and provide support for batch release process (review / approval deviations, status of approval of change, etc.).
- Work in collaboration with the Quality Assurance and CMC teams to evaluate any events affecting product quality, such as deviations or out-of-specification results, and help manage change controls performing the regulatory impact assessment.
Minimum Requirements:
- Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Biology, Pharmaceutical Sciences, or a related life sciences field.
- Previous experience (ideally, 5-7 years of experience) in Regulatory Affairs, GMP, or CMC in the pharmaceutical or biotech industry.
- Previous experience with Cell & Gene Therapies.
- Excellent English oral and written communication skills.
- Ability to work autonomously and prioritize workflow.
- Demonstrated analytical, problem resolution and communication skills.
- Strong communication and organizational skills to manage regulatory documents and collaborate with global regulatory bodies.
- Attention to detail, with the ability to manage multiple tasks in a regulated environment.
RAL and type of contract will be commensurate with seniority.
We will only consider candidates who will attach their Resume when applying.
We thank you in advance for expressing your interest in the Organization. We inform you that, due to the huge amount of applications received, we will be able to provide feedback only to those who will be contacted from Fondazione Telethon.
#J-18808-Ljbffr