Lavori attuali relativi a Regulatory Affairs Manager | Clinical Development - Bardi - Option One Life Science Consulting Sagl
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Medical Affairs Manager
4 giorni fa
Bardi, Italia Altro A tempo pienoOverview All Job Posting Locations: Milano, ItalyIn Johnson & Johnson crediamo che la salute sia tutto.Il nostro impegno nell'innovazione sanitaria ci consente di costruire un mondo in cui le malattie complesse vengono prevenute, trattate e curate, in cui i trattamenti sono più intelligenti e meno invasivi e le soluzioni sono personalizzate.At Johnson &...
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Medical Affairs Manager
4 giorni fa
Bardi, Italia Johnson & Johnson Innovative Medicine A tempo pienoOverviewAll Job Posting Locations: Milano, ItalyIn Johnson & Johnson crediamo che la salute sia tutto.Il nostro impegno nell'innovazione sanitaria ci consente di costruire un mondo in cui le malattie complesse vengono prevenute, trattate e curate, in cui i trattamenti sono più intelligenti e meno invasivi e le soluzioni sono personalizzate.At Johnson &...
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Medical Affairs Manager
4 giorni fa
Bardi, Italia Altro A tempo pienoOverviewAll Job Posting Locations: Milano, Italy In Johnson & Johnson crediamo che la salute sia tutto.Il nostro impegno nell'innovazione sanitaria ci consente di costruire un mondo in cui le malattie complesse vengono prevenute, trattate e curate, in cui i trattamenti sono più intelligenti e meno invasivi e le soluzioni sono personalizzate.At Johnson &...
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Medical Affairs Manager
4 giorni fa
Bardi, Italia Johnson & Johnson Innovative Medicine A tempo pienoOverviewAll Job Posting Locations: Milano, ItalyIn Johnson & Johnson crediamo che la salute sia tutto.Il nostro impegno nell'innovazione sanitaria ci consente di costruire un mondo in cui le malattie complesse vengono prevenute, trattate e curate, in cui i trattamenti sono più intelligenti e meno invasivi e le soluzioni sono personalizzate.At Johnson &...
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Medical Affairs Manager
58 minuti fa
Bardi, Italia Altro A tempo pienoOverview All Job Posting Locations: Milano, ItalyIn Johnson & Johnson crediamo che la salute sia tutto.Il nostro impegno nell'innovazione sanitaria ci consente di costruire un mondo in cui le malattie complesse vengono prevenute, trattate e curate, in cui i trattamenti sono più intelligenti e meno invasivi e le soluzioni sono personalizzate.At Johnson &...
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Freelance Clinical Project Manager
1 settimana fa
Bardi, Italia Epm Scientific A tempo pienoEPM Scientific are currently partnered with a Biotechnology company who are seeking a Freelance Clinical Project Manager to support their Rare Disease trials in Italy.See a short summary below: Contract Conditions: Start date: ASAP Location: Italy Contract: 0.8 - 1 FTE, 12-Month Contract Project: Rare Neuromusclar Disease - Phase 2 Trial Key Responsibilities...
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(Senior) Director Clinical Development
58 minuti fa
Bardi, Italia Sobi A tempo pienoJob DescriptionIncluding, but not limited to the following :Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standardsDesign, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other...
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(Senior) Director Clinical Development
60 minuti fa
Bardi, Italia Sobi A tempo pienoJob Description Including, but not limited to the following :Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standardsDesign, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other...
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Senior Clinical Research Associate
2 ore fa
Bardi, Italia Advanced Clinical A tempo pienoSenior Clinical Research Associate (Oncology)Working embedded with a leading global oncology-focused biopharmaceutical companyWe are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands-on clinical role.This...
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Global Regulatory Affairs Specialist
2 ore fa
Bardi, Italia Jefferson Wells Italia A tempo pienoOverviewSCOPO DEL RUOLO: Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with particular reference to EU.This role involves preparing regulatory dossiers, coordinating with health authorities,...
Regulatory Affairs Manager | Clinical Development
5 ore fa
Regulatory Affairs Manager | Clinical Development (CTA/IND) | EU/US/RoWABOUT / INFORegulatory Affairs professional with 7 - 10 years of experience in the pharmaceutical industry, supporting global clinical development programs across EU, US and RoW.Strong track record in managing clinical trial applications and maintenance activities (CTA/IND), coordinating complex submission packages, and ensuring compliance with international regulatory requirements (ICH/GCP).Experienced in regulatory strategy and execution, including formal meeting with major Regulatory Agencies.Experienced in the submission of ODD, PIP, NDA/BLA and MAA.Used to working in cross-functional environments, partnering closely with Clinical Operations, CMC, Pharmacovigilance, and external CROs to deliver high-quality dossiers within tight timelines.Key strengths include regulatory intelligence, critical thinking, structured problem-solving, and the ability to translate complex regulatory expectations into actionable project plans.Passionate about scientific innovation and contributing to projects addressing orphan drugs and unmet medical needs.Areas of expertiseGlobal CTA/IND/IMPD submissions and maintenanceMAA/NDA/BLA submissionsEU/US/RoW regulatory requirements for medicines licensesAuthority liaison and response managementDSUR / Annual Safety Reporting support and PV interfaceCross-functional coordinationHigh-quality document preparation and submission planningKeywords / SkillsRegulatory Affairs (Clinical Development)CTA / IND / IMPD submissionsMAA / NDA / BLAEU CTR / Clinical Trial RegulationCompetent Authorities interactionsRegulatory strategySubstantial amendmentsDSUR / ASRSUSAR reporting (oversight/coordination)ICH / GCP complianceClinical trial documentation (Protocol, IB, ICF, responses)Regulatory intelligence / guidelines monitoringODD / UMN therapeutic areasTarget rolesRegulatory Affairs R&D ManagerAreasPharma / BiotechAre you interested?Are you interested?Send your application or contact us directly for a confidential conversation.Option One Life Science Consulting – Connecting Compliance & Business#J-*****-Ljbffr
