Thermo Fisher Scientific | Senior Regulatory Affairs Specialist

Detalles de la oferta

.Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob 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.New Tasks and Responsibilities:Accountable and responsible for overseeing all submission types to Regulatory Authorities and/or EC/other local submissions, including North America IRB submissions.Manage country-specific local applications, overseeing the entire process from preparation to approval.Collect regulatory requirements and coordinate country-specific local applications, relying on RegView entries and follow-ups with CASs.Ensure adherence to standard RAL procedures applicable to EC and RA submissions.Oversee the development, translation, and filing of country and site-specific submission-related documents for RA, US IRBs and Canadian ECs submissionsEnsure that submission-related documents are received within the agreed timeline and filed according to agreed processes.Inform all Lead RAL and/or functional leads of the required deadlines for submission document availability.Liaise with Lead RAL and/or responsible functional leads in the CRG internal team to ensure documents required for submission are ready in time as per the submission plan.Working Conditions and Environment:Work is performed in an office environment with exposure to electrical office equipment.Occasional drives to site locations with occasional travel, both domestic and international.Physical Requirements:Coordinate all North America IRB activities and ensure that essential document quality meets the expectations of Regulatory Compliance Review


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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