Associate Regulatory Affairs Director I
hace 1 mes
Job Title: Associate Regulatory Affairs Director I Career Level - E Introduction to Role: Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This role offers the opportunity to work across varied stages and molecules, providing a dynamic and challenging environment that will expand your skills and knowledge.
Accountabilities: As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval. You will also provide regulatory expertise on procedural and documentation requirements to various teams, ensuring the delivery of business objectives. You may also be responsible for the maintenance of global labeling documents for allocated products and the planning and management of Regulatory and basic Clinical and Non-Clinical publishing deliverables.
Essential Skills/Experience: Relevant University Degree in Science or related discipline Minimum 9 years of relevant regulatory experience within the biopharmaceutical industry General knowledge of drug development Thorough knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Experience managing complex regulatory deliverables across projects/products Experience working with people from locations outside of India, especially Europe and/or USA Excellent English written and verbal communication skills Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (eg MS Project) and document management tools Ability to work independently and as part of a team Influencing and stakeholder management skills Ability to analyze problems and recommend actions Continuous Improvement and knowledge sharing focused Are you ready to be part of a dynamic team that's empowered to make quick decisions? Are you curious by nature, ready to dig into challenges to get to the core of a solution? If so, apply today
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Associate Regulatory Affairs Director I
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completoJob Title: Associate Regulatory Affairs Director ICareer Level - EIntroduction to Role:Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of...
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Associate Regulatory Affairs Director I
hace 1 mes
Barcelona, España AstraZeneca GmbH A tiempo completoJob Title: Associate Regulatory Affairs Director I Career Level - E Introduction to Role: Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution...
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Barcelona, España Astrazeneca Gmbh A tiempo completoJob Title: Associate Regulatory Affairs Director ICareer Level - EIntroduction to Role:Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of...
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Associate Director, Regulatory Affairs
hace 1 mes
Barcelona, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Locations: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology and Hepatology.Due...
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Associate Director, Regulatory Affairs
hace 4 semanas
Barcelona, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Location: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology.Due...
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Cmc Regulatory Affairs Associate Director
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...
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CMC Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoJob Title: CMC Regulatory Affairs Associate DirectorAbout the Role: We are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our cross-functional Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will collaborate with colleagues across the globe to ensure...
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Barcelona, España Astrazeneca A tiempo completoCMC Regulatory Affairs Associate Director BiologicsLocation - BarcelonaCompetitive salary and benefits packageIntroduction to roleJoin our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy, Biopharmaceutical and Global Supply...
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Regulatory Affairs Associate Director
hace 1 mes
Barcelona, España Sandoz A tiempo completo.As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation...
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Regulatory Affairs Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As Regulatory Affairs Associate Director, you will play a pivotal role in driving and delivering high-quality documentation to support successful submissions, ensuring timely and accurate reporting of regulatory activities, and coordinating the preparation and execution of regulatory documents.Key Responsibilities:• Lead, coach, and mentor...
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Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España Sandoz A tiempo completo.Detalles del empleo Tipo de empleo Jornada completa Ubicación Palafolls, Barcelona provincia Descripción completa del empleo As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project...
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Regulatory Affairs Director
hace 4 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API department, driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities to...
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Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring compliance with global regulatory standards. Your expertise in regulatory affairs will drive the development and implementation of regulatory strategies to support the company's business goals.Key Responsibilities:Lead a...
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Regulatory Affairs Associate Director
hace 1 mes
Barcelona, España Sandoz A tiempo completo.Detalles del empleoTipo de empleoJornada completaUbicaciónPalafolls, Barcelona provinciaDescripción completa del empleoAs Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project...
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Cmc Regulatory Affairs Director Biologics
hace 1 mes
Barcelona, España Astrazeneca A tiempo completo.CMC Regulatory Affairs Director BiologicsLocation: Barcelona, Spain (we require 3 days working from the office and 2 days working from home)Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development,...
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Regulatory Affairs Associate Director
hace 1 mes
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob Description SummaryLead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project plans. Including preparation of registration documentation and assessment of appropriateness of registration documentation for active...
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Regulatory Affairs Associate Director for CMC Specialists
hace 2 semanas
Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Associate Director to join our CMC team in Barcelona, Spain.Key Responsibilities* Provide strategic, tactical, and operational expertise to project teams* Develop creative strategies to support new biological entities and novel products* Collaborate with cross-functional teams to ensure...
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Regulatory Affairs Associate Director
hace 2 meses
Palafolls, Barcelona provincia, España Sandoz A tiempo completoAs Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...
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Cmc Regulatory Affairs Associate Director Biologics
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**CMC Regulatory Affairs Associate Director Biologics** **Location - Barcelona** **Competitive salary and benefits package** **Introduction to role** Join our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy,...
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Regulatory Affairs Associate Director
hace 2 meses
Barcelona, España Healthcare Businesswomen’S Association A tiempo completoJob Description Summary Lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project plans. Including preparation of registration documentation and assessment of appropriateness of registration documentation for active...
