Regulatory Affairs Manager CMC
hace 1 semana
Oxford Global Resources is seeking aGlobal CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma companyto 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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Regulatory Affairs Manager CMC
hace 1 semana
Madrid, España Oxford Global Resources A tiempo completoOxford Global Resources is seeking aAntes de solicitar este puesto, por favor, lea la siguiente información sobre esta oportunidad que encontrará a continuación.Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma companyto support headquartered in Barcelona through our consulting...
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Cmc strategist
hace 3 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge's Client is looking for an individual to help with their CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation@Spain (100 % Remote Working) Key area:Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely data...
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CMC Strategist
hace 2 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge’s Client is looking for an individual to help with their CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working) Key Area Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely...
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Global CMC Regulatory Affairs Manager
hace 17 horas
madrid, España Oxford Global Resources A tiempo completoA consulting firm is seeking an experienced Global CMC Regulatory Affairs Manager Consultant to provide regulatory insight and advice to teams for a leading pharmaceutical company in Madrid. The role involves ensuring compliance with global regulatory requirements and developing standard operating procedures. Ideal candidates will have at least 5 years of...
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CMC Strategist
hace 3 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge’s Client is looking for an individual to help with theirCMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working) Key area:Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely...
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CMC Strategist
hace 2 semanas
Madrid, España Smartedge Solutions A tiempo completoSmartedge’s Client is looking for an individual to help with theirCMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working) Key Area Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. Coordinate with manufacturing and quality teams to ensure accurate and timely...
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Senior Global CMC Regulatory Affairs Manager
hace 17 horas
madrid, España Oxford Global Resources A tiempo completoA leading consulting firm is seeking a Global CMC Regulatory Affairs Manager Consultant to support a top pharma company in Barcelona. This role involves providing regulatory insight, ensuring compliance with global regulations, and collaborating with various teams. Candidates must have a Bachelor's degree in Life Sciences, at least 5 years of experience in...
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Regulatory Affairs Manager CMC
hace 7 días
Madrid, España Oxford Global Resources A tiempo completoKey ResponsibilitiesProvide 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...
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Regulatory Affairs Manager CMC
hace 1 semana
madrid, España Oxford Global Resources A tiempo completoKey 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...
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Regulatory Affairs Technician-cmc
hace 1 semana
Madrid, España NonStop Consulting A tiempo completoTengo una nueva vacante como Regulatory Affairs Technician para trabajar en CMC para una importante empresa farmaceutica, el puesto es indefinido y hay muy buen ambiente laboral, ademas ofrecen muchas oportunidades de promocion. La vacante es office based con un dia de teletrabajo a la semana y el horario es flexible. **Responsabilidades**: Mantenerse...
