Regulatory Affairs Director
hace 4 semanas
Review and analyze study budgets and costing to inform contract negotiation and business development activities.
Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America regions, ensuring accurate compilation, management, and tracking of submissions.
Provide expert regulatory advice and contribute to regulatory project work, effectively communicating submission status with sponsors, project managers, CRAs, and medical and scientific affairs staff.
Contribute to the preparation of technical documentation, such as IMPDs and IBs, and review and make recommendations on relevant documentation to ensure compliance with ICH GCP and country-specific requirements.
Develop and deliver training, coaching, and mentoring programs for junior staff, and may be required to line manage junior team members.
RequirementsProven leadership and organizational management skills, with strong planning, strategizing, managing, monitoring, scheduling, and critiquing abilities.
Excellent written and verbal communication skills to present information clearly and concisely.
Strong relationship-building competency and ability to support business development at face-to-face meetings.
Excellent interpersonal skills in a fast-paced, deadline-oriented, and changing environment.
Ability to handle multiple tasks in a fast-paced and constantly changing environment.
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Regulatory Affairs Director
hace 1 mes
Madrid, Madrid, España Innovaderm Research A tiempo completoJob DescriptionJob Title: Regulatory Affairs DirectorJob Summary:Innovaderm Research is seeking a highly experienced Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Develop and...
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Regulatory Affairs Director
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
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Regulatory Affairs Director
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
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Regulatory Affairs Director
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Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsAbout the Role:We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Innovaderm Research. As a key member of our regulatory affairs group, you will be responsible for managing and overseeing the services provided by the Regulatory Affairs team in assigned regions.Key...
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Regulatory Affairs Director
hace 4 semanas
Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsAbout the Role:We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Innovaderm Research. As a key member of our regulatory affairs group, you will be responsible for managing and overseeing the services provided by the Regulatory Affairs team in assigned regions.Key...
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Regulatory Affairs Director
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Regulatory Affairs Director
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Madrid, Madrid, España Innovaderm Research A tiempo completoJob Title: Associate Director, Regulatory AffairsJob Summary:The Associate Director, Regulatory Affairs is a key member of our team, responsible for overseeing the Regulatory Affairs group in assigned regions. This role ensures that all regulatory activities are conducted according to Innovaderm's standard operating procedures, applicable regulations, and...
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Regulatory Affairs Director
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Madrid, Madrid, España Worldwide Clinical Trials, LLC A tiempo completo{"title": "Regulatory Affairs Manager", "content": "Regulatory Affairs ManagerAt Worldwide Clinical Trials, LLC, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Review and manage...
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Regulatory Affairs Director
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Madrid, Madrid, España Worldwide Clinical Trials, LLC A tiempo completo{"title": "Regulatory Affairs Manager", "content": "Regulatory Affairs ManagerAt Worldwide Clinical Trials, LLC, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Review and manage...
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Regulatory Affairs Director
hace 4 semanas
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Regulatory Affairs Director
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Regulatory Affairs Director
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Regulatory Affairs Specialist
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