Regulatory Compliance Manager
hace 2 semanas
Job Title: Quality and Regulatory Director Location: Paterna, Spain Reports to: Chief Operating Officer (COO) Department: Quality / Senior Leadership Team Position Overview: We are seeking a highly experienced Quality and Regulatory Director to lead our Quality Control, Quality Assurance, and Regulatory Affairs functions. As a senior leader, you will shape and execute the company’s quality and regulatory strategy, ensuring operations and products meet all GxP standards and regulatory requirements. You will be instrumental in preparing for FDA inspections, including a Pre-Approval Inspection (PAI) in 2026, and in implementing and maintaining eQMS and LIMS systems in full compliance with regulatory standards. Key Responsibilities Lead regulatory strategies to ensure compliance with FDA, EMA, ISO, and ICH guidelines. Act as a subject matter expert for regulatory affairs, including approvals for API, drug products, and novel excipients. Prepare the organization for FDA PAI inspections and act as Qualified Person for batch certification and release. Lead implementation, validation, and oversight of eQMS and LIMS systems. Drive internal audits, gap assessments, and CAPA processes, ensuring inspection readiness. Oversee Quality Control and Quality Assurance teams, ensuring products meet all quality standards. Prepare and submit regulatory filings (INDs, NDAs, BLAs, CTDs, DMFs) and interpret regulatory feedback. Collaborate with cross-functional teams to ensure regulatory compliance throughout product development. Lead, mentor, and develop Quality and Regulatory teams, fostering high performance and professional growth. Build and maintain strong relationships with customers and regulatory agencies. Establish risk management strategies related to regulatory and quality compliance. Drive operational excellence, process improvements, and efficiency in regulatory operations. Qualifications & Experience Bachelor’s degree in Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or related field; Master’s or MBA preferred. Minimum 7 years of experience in quality and regulatory affairs within the pharmaceutical or CDMO sector. Proven track record of leading regulatory approvals for API, drug products, and novel excipients. Strong expertise in FDA / EMA regulations, GxP standards, and eQMS / LIMS implementation and validation. Experience preparing for FDA inspections, particularly Pre-Approval Inspections (PAI). Extensive experience in regulatory submissions (INDs, NDAs, CTDs, DMFs, BLAs) for chemical and biologic products. Demonstrated leadership in cross-functional teams, with the ability to recruit, motivate, and develop high‑performing teams. Strong stakeholder management and relationship‑building skills with regulatory agencies and customers. Fluent in English; Spanish working proficiency preferred. Excellent problem‑solving, analytical, organizational, and strategic thinking skills. #J-18808-Ljbffr
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Regulatory Compliance Manager
hace 3 días
Madrid, España Ebury A tiempo completoJoin to apply for the Regulatory Compliance Manager role at Ebury Ebury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in 2009, we’ve grown to a diverse team of over 1,700 professionals across 40+ offices and 29+ markets worldwide. Joining...
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Regulatory Compliance Manager
hace 1 semana
Madrid, España Ebury A tiempo completoEbury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in , we’ve grown to a diverse team of over 1, professionals across 40+ offices and 29+ markets worldwide. Joining Ebury means becoming part of a collaborative and innovative environment...
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Regulatory Compliance Manager
hace 5 días
Madrid, España Ebury A tiempo completoJoin to apply for the Regulatory Compliance Manager role at EburyEbury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in 2009, we’ve grown to a diverse team of over 1,700 professionals across 40+ offices and 29+ markets worldwide. Joining...
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Regulatory Compliance Manager
hace 1 día
Madrid, España Ebury A tiempo completoEbury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in 2009, we've grown to a diverse team of over 1,700 professionals across 40+ offices and 29+ markets worldwide. Joining Ebury means becoming part of a collaborative and innovative...
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Regulatory Compliance Manager
hace 2 semanas
Madrid, España Dojo.tech A tiempo completoES Madrid | Legal & Compliance Ireland | 21 Aug 2024 | R-0003633 **Diversity, equity, and inclusion at Dojo**: From local bakeries to well-known eateries, Dojo payments serve over 140,000 places across the UK. And something that’s fundamental to creating relevant, innovative products at Dojo is to build teams to reflect the diversity of the businesses we...
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Regulatory Compliance Manager
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Madrid, España Revolut A tiempo completoJoin to apply for the¿Posee las habilidades y la experiencia adecuadas para este puesto? Siga leyendo para descubrirlo y envíe su solicitud.Regulatory Compliance Manager (France)role atRevolut3 days ago Be among the first 25 applicantsJoin to apply for theRegulatory Compliance Manager (France)role atRevolutGet AI-powered advice on this job and more...
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Regulatory Compliance Manager
hace 1 semana
Madrid, Madrid, España Ebury A tiempo completoEbury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in 2009, we've grown to a diverse team of over 1,700 professionals across 40+ offices and 29+ markets worldwide. Joining Ebury means becoming part of a collaborative and innovative...
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Regulatory Compliance Analyst
hace 3 días
Madrid, España Ebury A tiempo completoEbury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in , we’ve grown to a diverse team of over 1, professionals across 40+ offices and 29+ markets worldwide. Joining Ebury means becoming part of a collaborative and innovative environment...
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Regulatory Compliance Analyst
hace 1 día
madrid, España Ebury A tiempo completoCompliance Analyst Ebury is a global fintech firm dedicated to empowering businesses to expand internationally through tailored and forward-thinking financial solutions. Since our founding in 2009, we’ve grown to a diverse team of over 1,700 professionals across 40+ offices and 29+ markets worldwide. Joining Ebury means becoming part of a collaborative and...
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Regulatory Compliance Manager
hace 3 semanas
Madrid, España ARTO A tiempo completoJob Title:Quality and Regulatory Director Location:Paterna, Spain Reports to:Chief Operating Officer (COO) Department:Quality / Senior Leadership Team Position Overview: We are seeking a highly experiencedQuality and Regulatory Directorto lead our Quality Control, Quality Assurance, and Regulatory Affairs functions. As a senior leader, you will shape and...
