Cmc Regulatory Senior Specialist
3 settimane fa
On behalf of our client - an important pharmaceutical group - we are looking for a CMC Regulatory Senior Specialist. This role ensures high-quality content for regulatory CMC documentation in line with applicable guidelines for new and approved Drug Products and/or Drug Substances of the Company Group in Europe, the USA, and other countries.
Key Responsibilities: Authoring of CMC sections (Drug Product and/or Drug Substance) of the registration dossier for new applications in CTD format in line with the Global regulatory strategies and the most current regulatory guidelines.Authoring and review of CMC sections to support variations.Gap Analysis and/or Due Diligences of Quality Parts of Global Dossier(s).Ensure regulatory compliance of CMC sections of global products and drug substances throughout the product lifecycle.Evaluation of regulatory impact of quality change controls.Support to QA function during Health Authorities' inspections.Support to QA and Virtual Plant for Third parties Qualification (CMO).Publishing and/or creation of eCTD sequences related to CMC sections.This is a permanent role within the company production site in Frosinone.
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Cmc Regulatory Senior Specialist
7 mesi fa
Lazio, Italia Jefferson Wells A tempo pienoOn behalf of our client - important pharmaceutical group - we are looking for a CMC Regulatory Senior Specialist Ensuring high quality contents for regulatory CMC documentation in line with applicable guidelines for new and approved Drug Products and/or Drug Substances of Company Group in Europe, USA and other countries.Key Responsibilities: Authoring of CMC...
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Cmc Regulatory Senior Specialist
3 settimane fa
Lazio, Italia Buscojobs A tempo pienoOn behalf of our client - an important pharmaceutical group - we are looking for a CMC Regulatory Senior Specialist. This role ensures high-quality content for regulatory CMC documentation in line with applicable guidelines for new and approved Drug Products and/or Drug Substances of the Company Group in Europe, the USA, and other countries. Key...
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Regulatory Affairs Cmc Specialist
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Lazio, Italia Eusa Pharma A tempo pienoJob PurposeWe are looking for a Regulatory Affairs CMC Specialist who has consolidated experience on Chemistry, Manufacturing and Control (CMC) aspects in order to manage the preparation of dossiers for submission to regulatory authorities worldwide.Key ResponsibilitiesWriting and managing technical sections of Module 3 in collaboration with relevant...
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Regulatory Cmc Manager
2 mesi fa
Lazio, Italia Tfs Healthscience A tempo pienoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey.We provide full-service capabilities , resourcing , and Functional Service Provider (FSP) solutions , helping bring life-saving treatments to patients worldwide.Sponsor:...
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Regulatory Cmc Manager
3 settimane fa
Lazio, Italia Buscojobs A tempo pienoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...
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Regulatory Cmc Manager
3 settimane fa
Lazio, Italia Buscojobs A tempo pienoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide. Sponsor:...
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Lazio, Italia Merck A tempo pienoWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix...
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Senior Regulatory Affairs Specialist Api
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Lazio, Italia Confidenziale A tempo pienoCategoria: Healthcare / PharmaceuticalLuogo di lavoro: ItaliaSenior Regulatory Affairs Specialist Active Pharmaceutical IngredientsCompetenze Chiave richieste: Ottima conoscenza della Regolamentazione in ambito API;scrittura e implementazione EU-CTD module 3scrittura e implementazione US DMT type II;scrittura e implementazione J-DMF;Wscrittura e...
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Director, Regulatory Affairs, Cmc
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Lazio, Italia Buscojobs A tempo pienoJob Description - Director, Regulatory Affairs, CMC - Combination Products (220858) Overview: The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product / Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program...
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Director, Regulatory Affairs, Cmc
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Lazio, Italia Buscojobs A tempo pienoJob Description - Director, Regulatory Affairs, CMC - Combination Products (220858) Overview: The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product / Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program...
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Director, Regulatory Affairs, Cmc
3 settimane fa
Lazio, Italia Buscojobs A tempo pienoJob Description - Director, Regulatory Affairs, CMC - Combination Products (220858) Overview: The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product / Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program...
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Senior Regulatory Affairs Specialist Api
1 settimana fa
Lazio, Italia Buscojobs IT C2 A tempo pienoCategoria:Healthcare / PharmaceuticalLuogo di lavoro:ItaliaSenior Regulatory Affairs Specialist Active Pharmaceutical IngredientsCompetenze Chiave richieste:Ottima conoscenza della Regolamentazione in ambito API;scrittura e implementazione EU-CTD module 3scrittura e implementazione US DMT type II;scrittura e implementazione J-DMF;Wscrittura e implementazione...
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Regional Director, Regulatory Affairs
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Lazio, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health.From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...
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Lazio, Italia Buscojobs A tempo pienoNonStop Pharma , per conto di un'azienda cliente in forte espansione e con un approccio altamente innovativo, è alla ricerca di un* CMC Specialist motivat*, desideros* di intraprendere un percorso di crescita in un ambiente dinamico e stimolante.Questa è un'opportunità unica per entrare a far parte di una realtà di riferimento nel settore farmaceutico,...
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Manager, Regulatory Affairs
2 settimane fa
Lazio, Italia Thermo Fisher Scientific A tempo pienoOur site in Ferentino is part of Pharma Services of Thermo Fisher Scientific. We are looking for a talent in Regulatory Affairs Lead for our complex and highly regulated environment within the DPD sterile business unit.**RESPONSIBILITIES**:Regulatory CMC Services:- Assist in quotations preparation and enable proposal at different stages:- Evaluate regulatory...
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Manager, Regulatory Affairs
2 settimane fa
Lazio, Italia Thermo Fisher Scientific A tempo pieno**JOB SUMMARY**:Our site in Ferentino is part of Pharma Services of Thermo Fisher Scientific. We are looking for a talent in Regulatory Affairs Lead for our complex and highly regulated environment within the DPD sterile business unit.**RESPONSIBILITIES**:Regulatory CMC Services:- Assist in quotations preparation and enable proposal at different stages:-...
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Regulatory Affairs Project Manager
1 settimana fa
Lazio, Italia Pqe Group A tempo pienoSenior Talent Acquisition Specialist presso PQE GroupSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device?PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in...
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Regulatory Affairs Project Manager
1 settimana fa
Lazio, Italia Pqe Group A tempo pienoSenior Talent Acquisition Specialist presso PQE GroupSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device?PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in...
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Regulatory Affairs Project Manager
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Lazio, Italia Pqe Group A tempo pienoSenior Talent Acquisition Specialist presso PQE Group Sei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe....
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Regulatory Affairs Consultant
2 settimane fa
Lazio, 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.PPL.24.007)_ da inserire all'interno della nostra divisione degli**affari regolatori**.**Regulatory Affairs di almeno...