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.
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Regulatory Affairs Manager
hace 6 días
Catalonia, España 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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Senior Regulatory Strategist
hace 1 semana
Catalonia, España 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 Compliance Manager
hace 2 semanas
Catalonia, España ARTO A tiempo completoPosition OverviewThe 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 and Regulatory Director
hace 2 días
Catalonia, España 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 and Regulatory Director
hace 2 días
Catalonia, España 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
Catalonia, España elemed A tiempo completoTitle : RAQA Lead - Spain and Portugal Location : Barcelona, Spain Contact : The company Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and...
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Quality regulatory manager
hace 6 días
Catalonia, España Elemed A tiempo completoTitle: RAQA Lead - Spain and Portugal Location: Barcelona, Spain Contact: The company Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons...
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Regulatory Affairs Associate
hace 2 semanas
Catalonia, España Vetpharma A tiempo completoWho we are?Veterinary medicine manufacturersVetpharma 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 are a highly qualified team.We have extensive experience in development, registration and marketing veterinary medicinal...
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Regulatory affairs associate
hace 6 días
Catalonia, España Vetpharma A tiempo completoWho we are? 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 are a highly qualified team. We have extensive experience in development, registration and marketing veterinary...
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Regulatory Affairs Associate
hace 1 semana
Catalonia, España Vetpharma A tiempo completoWho we are? 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 are a highly qualified team. We have extensive experience in development, registration and marketing veterinary...
