Associate Regulatory Affairs Director I
hace 2 semanas
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 2 semanas
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 semana
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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Regulatory Affairs Associate Director
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Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's compliance with global regulatory standards. Your key responsibilities will include:Leading a team of regulatory associates to drive high-quality documentation and...
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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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Cmc Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completo.CMC Regulatory Affairs Associate Director Location: 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...
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Cmc Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completoCMC Regulatory Affairs Associate Director Location: 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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Cmc Regulatory Affairs Associate Director
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Barcelona, España Astrazeneca A tiempo completo.CMC Regulatory Affairs Associate DirectorLocation: 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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Cmc Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completoCMC Regulatory Affairs Associate DirectorLocation: 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 semana
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a key member of our Regulatory Affairs team, you will play a critical role in driving and delivering high-quality documentation to support successful submissions, while ensuring compliance with current global regulatory standards.Key Responsibilities:Lead and mentor associates to ensure maximum regulatory...
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Associate Director, Regulatory Affairs
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Cmc Regulatory Affairs Associate Director
hace 1 mes
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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Regulatory Affairs Associate Director
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Barcelona, Barcelona, España Sandoz A tiempo completoJob DescriptionAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's products comply with global regulatory standards. Your key responsibilities will include:Leading and mentoring a team of regulatory associates to drive high-quality documentation and...
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Regulatory Affairs Associate Director
hace 1 semana
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a key member of our Regulatory Affairs team, you will play a critical role in ensuring the success of our regulatory submissions. Your expertise will be essential in driving high-quality documentation and ensuring compliance with global regulatory standards.Key Responsibilities:Lead and mentor a team of...
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CMC Regulatory Affairs Associate Director
hace 3 días
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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Regulatory Affairs Associate Director
hace 7 días
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department, responsible for driving and delivering high-quality documentation to support successful submissions. Your key responsibilities will include:Leading, coaching, and mentoring associates to ensure they have the...
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Regulatory Affairs Associate Director
hace 7 días
Barcelona, Barcelona, España Sandoz A tiempo completoJob SummaryAs 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 objectives.Key...
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Regulatory Affairs Associate Director
hace 2 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAt Sandoz, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Job Summary:We are seeking a highly skilled Regulatory Affairs Associate Director to lead our Regulatory API (RAPI) team. As a key member of our regulatory...
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Regulatory Affairs Associate Director
hace 2 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAt Sandoz, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Job Summary:We are seeking a highly skilled Regulatory Affairs Associate Director to lead our Regulatory API (RAPI) team. As a key member of our regulatory...
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Regulatory Affairs Associate Director
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Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAt Sandoz, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Job Summary:We are seeking a highly skilled Regulatory Affairs Associate Director to lead our Regulatory API (RAPI) team. As a key member of our regulatory...
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Regulatory Affairs Associate Director
hace 2 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAt Sandoz, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Job Summary:We are seeking a highly skilled Regulatory Affairs Associate Director to lead our Regulatory API (RAPI) team. As a key member of our regulatory...
