Global Regulatory Affairs Lead
hace 4 meses
.Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your applicationAt Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:Competitive compensation for your workEmphasis on work/life balanceCollaborative and team-oriented environmentOpportunities for professional growthDiversity and InclusionMaking a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob DescriptionKey Responsibilities and Accountabilities:Including, but not limited to the following:Single point of contact/single point of accountability within GRA on the Core Asset Team (CAT) and Medicines Development Team (MDT) for assigned program(s)Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)Provides global regulatory leadership of assigned program(s)Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients' accessAttends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s)May present to Senior Leadership regarding assigned program(s)Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultantsParticipates in strategic and regulatory evaluations of in-licensing mattersMay have direct oversight/management of Regulatory Affairs team members supporting assigned program(s)Authority to approve services and costs within budget and delegation from Sobi authorized signatoriesReview regulatory SOPs as neededParticipate in operational excellence work (improvement projects) as needed.Main contacts:Internal core interactions: All functions within Sobi, but in particular Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management as well as Management Teams, Governance Teams and affiliates.External core interactions with: Regulatory Authorities, CROs, Consultants, Partners.May act as point of contact with US FDA or EMA
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Global Regulatory Affairs Lead
hace 1 mes
Madrid, Madrid, España Sobi - Swedish Orphan Biovitrum AB (publ) A tiempo completoJob DescriptionSobi is a global biopharmaceutical company dedicated to rare diseases. We are seeking a highly skilled Global Regulatory Affairs Lead to join our team.Key Responsibilities:Provide global regulatory leadership for assigned programs, developing strategies and risk assessments.Chair the Global Regulatory Team and attend critical regulatory agency...
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Regulatory Affairs Expert
hace 4 semanas
Madrid, Madrid, España Sobi Group A tiempo completoKey Responsibilities and Accountabilities:Global Regulatory LeadershipThe Global Regulatory Affairs Lead provides global regulatory leadership of assigned programs, developing global regulatory strategies, including risk assessment and mitigation strategies. This role chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) and is the...
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Global Regulatory Affairs Lead
hace 4 meses
Madrid, España Sobi - Swedish Orphan Biovitrum AB (publ) A tiempo completoStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, each person brings their unique talents to work as a team and make a difference....
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Global Regulatory Affairs Lead
hace 4 meses
Madrid, España Sobi - Swedish Orphan Biovitrum AB (publ) A tiempo completoStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi, each person brings their unique talents to work as a team and make a difference....
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Vice President, Regulatory Affairs
hace 4 semanas
Madrid, España Precision Medicine Group A tiempo completo.Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Vice President, Regulatory Affairs
hace 6 meses
Madrid, España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Oatly A tiempo completoOatly, the original oatmilk company, is expanding its presence in North America and seeks a highly skilled Regulatory Affairs Manager to join our team. As the leader of our US-based regulatory affairs function, you will provide expert guidance on food law and compliance matters.About the Role:This role involves leading the Oatly North America Regulatory...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Astrazeneca A tiempo completo.1. MISIÓNImplantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables.2. RESPONSABILIDADESGestión y...
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Madrid, Madrid, España Parexel A tiempo completoUnlocking Global Potential At Parexel, we're committed to accelerating the time to market for our clients' late-stage phase III assets. To achieve this ambitious goal, we're seeking experienced Regulatory Affairs professionals to join our dynamic team in support of a global acceleration client initiative. As a key member of our global regulatory team,...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Astrazeneca A tiempo completo.1. MISIÓN Implantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables. 2. RESPONSABILIDADES Gestión y...
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Global Regulatory Affairs Strategist
hace 1 semana
Madrid, Madrid, España Parexel A tiempo completoParexel's Global Regulatory Acceleration InitiativeWe are seeking an experienced Regulatory Affairs professional to join our dynamic team in support of a global acceleration client initiative for late-stage phase III assets.This is an exciting opportunity to play a crucial role in accelerating time to filing and approval in Global Country Initiative (GCI),...
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Vice President, Regulatory Affairs
hace 4 semanas
Madrid, España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Vice President, Regulatory Affairs
hace 4 semanas
Madrid, España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Vice President, Regulatory Affairs
hace 4 semanas
Madrid, España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO.At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Senior Manager, Regulatory Affairs
hace 2 días
Madrid, España Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...
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Regulatory Affairs Manager
hace 3 semanas
Madrid, España AstraZeneca A tiempo completo**1. MISIÓN** Implantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables. **2....
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Clinical Strategy Director
hace 1 semana
Madrid, Madrid, España STRAGO A tiempo completoSTRAGO Healthcare is a leading global consultancy that provides top-tier talent services to major Healthcare and Life Sciences organizations worldwide.We are seeking an experienced Clinical Strategy Director - Regulatory Affairs to provide expert strategic advice on clinical and regulatory matters for global drug development projects. In this role, you will...
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Vice President, Regulatory Affairs
hace 4 semanas
Madrid, España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Senior Regulatory Affairs Director
hace 4 semanas
Madrid, Madrid, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs Medical Device Lifecycle ManagementAt Cpl Healthcare, we are seeking an experienced Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join our Pharmaceutical team.This key role will be responsible for the strategic lifecycle management of our Medical Device portfolio, ensuring...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, Madrid, España TRIUM Clinical Consulting NV A tiempo completoAbout the RoleWe are seeking a highly experienced Senior Regulatory Affairs Officer to join our team at QbD Group in Spain. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with pharmaceutical legislation and regulations.With a strong background in regulatory affairs, you will have expertise in ICH...
