Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob DescriptionThe North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical requirements. The RAL acts as a liaison with internal and external clients and oversees the preparation and submission of regulatory documentation.Essential Functions:Support the preparation of documentation and submissions under guidance.Coordinate and manage client deliverables ensuring regulatory compliance.Liaise with internal and external clients to track and update the status of long-range planning, adapting to changing priorities and handling multiple projects.Exhibit good negotiation skills and the capability to work independently with direction, exercising independent judgment.Independently assess sponsor regulatory needs and collaborate with project team members to produce compliant deliverables.Possess basic knowledge of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.Understand medical terminology, statistical concepts, and guidelines.Demonstrate good analytical, investigative, and problem-solving skills, with the ability to interpret data.

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob DescriptionThe North American Regulatory Affairs Lead (RAL) provides innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization. This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical requirements. The RAL acts as a liaison with internal and external clients and oversees the preparation and submission of regulatory documentation.Essential Functions:

Want more jobs like this?Getjobsthat areRemotedelivered to your inbox every week.

Want more jobs like this?

Getjobsthat areRemotedelivered to your inbox every week.

Get Jobs