Regulatory Affairs Manager | Clinical Development
11 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-18808-Ljbffr
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Turbigo, Italia Option One Life Science Consulting Sagl A tempo pienoA leading life science consulting firm is seeking a Regulatory Affairs Manager to support global clinical development programs. The ideal candidate will have 7-10 years of experience in the pharmaceutical industry, with a strong background in managing clinical trial applications, including CTA/IND submissions and compliance with regulatory requirements...
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turbigo, Italia Option One Life Science Consulting Sagl A tempo pienoA leading life science consulting firm is seeking a Regulatory Affairs Manager to support global clinical development programs. The ideal candidate will have 7-10 years of experience in the pharmaceutical industry, with a strong background in managing clinical trial applications, including CTA/IND submissions and compliance with regulatory requirements...
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Turbigo, Italia Option One Life Science Consulting Sagl A tempo pienoRegulatory Affairs Manager | Clinical Development (CTA/IND) | EU/US/RoW ABOUT / INFO Regulatory 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),...
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Turbigo, Italia Option One Life Science Consulting Sagl A tempo pienoRegulatory 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...
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Medical Affairs Manager
16 ore fa
Turbigo, 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
11 ore fa
turbigo, 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
16 ore fa
Turbigo, Italia Johnson & Johnson Innovative Medicine A tempo pienoOverview All 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
16 ore fa
Turbigo, Italia Johnson & Johnson Innovative Medicine A tempo pienoOverview All 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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(Senior) Director Clinical Development
16 ore fa
Turbigo, 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
14 ore fa
Turbigo, 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 standards Design, 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...
