Regulatory Affairs Manager CMC
hace 7 días
Oxford Global Resources is seeking a Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company to support headquartered in Barcelona through our consulting services division. Key Responsibilities: Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC technical functions on CMC/Quality regulations and guidelines according to the Agencies expectations for successful approvals. Provide significant contribution or leading efforts for the authoring of CMC documents for the submission to Health Authorities (HA), including MAA preparation, post-approval variations and responses to HA questions, as well as IMPDs for products under development. Coordinate any CMC regulatory activity required to expand the company portfolio in different territories (e.g. LATAM, APAC, EMA), in close collaboration with internal stakeholders (International Pharma Sales, affiliates, CMO management, etc) as well as partners and potential vendors. Collaborate in the assessment of Business Development opportunities in relation to CMC topics. Ensure compliance with global regulatory requirements and contribute to the development of internal global standard operating procedures and guidance documents as needed. Establish good collaboration and interactions across various functions and teams, such as manufacturing sites (CMOs), Quality Assurance, supply chain, etc Ensure to be up to date with CMC regulatory intelligence relevant to the company portfolio and pipeline. Requirements, Skills, and Qualifications: Bachelor's degree in Life Sciences or a related field. Fluency in English for business communication. Minimum 5 years in Regulatory CMC field for pharmaceutical products, ideally at a global level. Strong scientific and technical CMC knowledge, along with strategic regulatory mindset. Good knowledge of international CMC regulatory legislation. Proven track record of effective collaboration with CMOs, partners and Health Authorities in gaining regulatory approvals and managing life cycle of approved products in different geographical areas. Demonstrable submission history experience for EU and other international territories Knowledge of regulatory frameworks for medical devices and food supplements desirable.
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Senior regulatory strategist
hace 7 días
Gibraltar-Spain Neutral Zone G&L Scientific A tiempo completoThis role can be based in either our Barcelona , Belfast or London Office. We work on a hybrid basis.Ready to dive into some seriously meaningful science? We're looking for a seasoned CMC Regulatory Affairs pro who loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You'll step in as our Senior...
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Regulatory Affairs Project ManagerNonStop Consulting
hace 1 semana
spain NonStop Consulting A tiempo completoRegulatory Affairs Project Manager Location: Remote/Home Working EU Wide Introduction Our client is seeking a highly skilled and motivated Regulatory Affairs Project Manager to join their dynamic team. This role offers the opportunity to work at the forefront of regulatory science, contributing to the successful registration and market approval of active...
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spain NonStop Consulting A tiempo completoRegulatory Affairs Project Manager Introduction Our client is seeking a highly skilled and motivated Regulatory Affairs Project Manager to join their dynamic team. This role offers the opportunity to work at the forefront of regulatory science, contributing to the successful registration and market approval of active substances under EU Regulation 1107/2009...
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spain NonStop Consulting A tiempo completoRegulatory Affairs Project Manager Introduction Our client is seeking a highly skilled and motivated Regulatory Affairs Project Manager to join their dynamic team. This role offers the opportunity to work at the forefront of regulatory science, contributing to the successful registration and market approval of active substances under EU Regulation 1107/2009...
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Quality And Regulatory Director
hace 2 semanas
Spain ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization's overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality Regulatory Manager
hace 2 semanas
Spain Elemed A tiempo completoTitle : RAQA Lead - Spain and Portugal Location : Barcelona, Spain Contact : ¿Está considerando presentar su candidatura para este trabajo? Compruebe todos los detalles en esta descripción del puesto y luego haga clic en "Solicitar". The company Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical...
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Quality Regulatory Manager
hace 2 semanas
Spain Elemed A tiempo completoTitle: RAQA Lead - Spain and Portugal Location: Barcelona, Spain Contact: Aunque la experiencia profesional y las cualificaciones son clave para este puesto, asegúrese de comprobar si posee las habilidades interpersonales preferibles antes de solicitar, si se requieren. The companyAre you someone who has Iberia-wide regulatory experiences and are looking...
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Quality And Regulatory Director
hace 2 semanas
Spain 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 experienced Quality and Regulatory Director to lead our Quality Control, Quality Assurance, and Regulatory Affairs functions. As a senior leader, you will shape...
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Clinical Affairs Program Manager Spain
hace 1 semana
spain Chronos Consulting A tiempo completoJob Description Our client is a global medical device company, a pioneer of the MR-guided focused ultrasound technology which is a game-changing innovation. They are looking for a Clinical Affairs Program Manager Europe. The role is % remote with up to 40% travel and based in Europe. As part of the global clinical affairs team, you will be responsible for...
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Regulatory Affairs Associate
hace 1 semana
Spain Vetpharma A tiempo completoWho we are? ¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación.Veterinary medicine manufacturers Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977. In Vetpharma we...
