Regulatory Affairs Manager CMC
hace 1 semana
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, etcEnsure 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 territoriesKnowledge of regulatory frameworks for medical devices and food supplements desirable. #J-18808-Ljbffr
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Regulatory Affairs Manager CMC
hace 3 semanas
Barcelona, España Oxford Global Resources A tiempo completoOxford 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.Envíe su solicitud a continuación después de leer todos los detalles y la información de apoyo sobre esta...
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Regulatory Affairs Manager CMC
hace 2 semanas
Barcelona, España Oxford Global Resources A tiempo completoOxford 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. Envíe su solicitud a continuación después de leer todos los detalles y la información de apoyo sobre esta...
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Regulatory Affairs Associate
hace 7 días
barcelona, España Inter Regulatory A tiempo completoRegulatory Affairs Associate (Medicines) Company: Inter Regulatory Employment Type: Full-time About the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub . This role is suited to a...
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Regulatory Affairs Associate
hace 1 semana
Barcelona, España Inter Regulatory A tiempo completoRegulatory Affairs Associate (Medicines) Company: Inter RegulatoryEmployment Type: Full-timeAbout the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub .This role is suited to a...
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Barcelona, España Jordan martorell s.l. A tiempo completoA top leading pharmaceutical consultancy is seeking a Global CMC Regulatory Affairs Manager Consultant to provide regulatory insight and manage submissions for a major pharmaceutical client headquartered in Barcelona. The role demands at least 5 years of experience in regulatory CMC and strong collaboration with CMOs and Health Authorities. The consultant...
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Regulatory Affairs Associate
hace 1 semana
Barcelona, España Inter Regulatory A tiempo completoA growing regulatory consultancy in Barcelona is seeking a Regulatory Affairs Associate with 3-5 years of experience in pharmaceutical Regulatory Affairs. The role involves authoring and managing regulatory dossiers, handling CMC documentation, and supporting US regulatory applications. Candidates should have a scientific degree and be fluent in English and...
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International Cmc Regulatory Affairs Director
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the potential of science, then you are the perfect fit for us. Join our Chemistry,...
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Senior CMC Regulatory Affairs Specialist
hace 1 semana
Barcelona, España Project Delivery Partners Pte Ltd A tiempo completoA leading consulting firm in Barcelona seeks a dedicated Senior CMC RA Specialist. This on-site role focuses on ensuring regulatory compliance in Chemistry, Manufacturing, and Controls (CMC) documentation. The ideal candidate has over 10 years of experience in Regulatory Affairs within the pharmaceutical industry, strong knowledge of GMP and ICH guidelines,...
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Senior CMC Regulatory Affairs Specialist
hace 1 semana
barcelona, España Project Delivery Partners Pte Ltd A tiempo completoA leading consulting firm in Barcelona seeks a dedicated Senior CMC RA Specialist. This on-site role focuses on ensuring regulatory compliance in Chemistry, Manufacturing, and Controls (CMC) documentation. The ideal candidate has over 10 years of experience in Regulatory Affairs within the pharmaceutical industry, strong knowledge of GMP and ICH guidelines,...
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Barcelona Regulatory Affairs Lead
hace 2 minutos
Barcelona, España Project Delivery Partners Pte Ltd A tiempo completoA leading pharmaceutical consulting company in Barcelona is seeking a Regulatory Affairs Expert to ensure compliance of Chemistry, Manufacturing, and Controls documentation. In this role, you will prepare documentation packages, assess CMC changes, and collaborate with teams to maintain accuracy. The ideal candidate has a relevant degree and over 5 years of...
