Senior Regulatory Affairs Coordinator

Overview Regulatory Affairs Specialist (LATAM) responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and...

A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large...

Ensure that the BWE process of regulatory compliance assessment and monitoring is in place. - Ensure that all operational-related contractors and BWE operations in Brazil are recurrently assessed and monitored regarding regulatory requirements. - Ensure that all activities, for which is under this one responsible, are carried out in conformance with laws and...

Define the scope and deadlines for deliverables that sustain compliance with applicable regulatory requirements, observing production schedules and budgets. - Support the definition of responsibilities and resources to achieve regulatory compliance efficiently, observing the BWE organization charts and budgets. - Incorporate lessons learned to BWE, set...

Job Overview Our Senior Regulatory Specialist will be the primary contact with investigative sites during site start-up activities and maintenance. They will be responsible for collecting the required investigator and essential documents to ensure timely submission to EC/IRB/Third body/Regulatory Authority and that documentation meets applicable regulations...

**ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED!** **Essential Functions**: - Assist/Advise project teams on all regulatory requirements for clinical studies - Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings - Review and adapt study specific...

**ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED!****Essential Functions**:- Assist/Advise project teams on all regulatory requirements for clinical studies- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings- Review and adapt study specific...

Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site...

Medical, Regulatory & PV Specialist**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Podgorica, Podgorica, RS**The Position**- As a Medical, Regulatory and Pharmacovigilance Specialist at Novo Nordisk, you will secure timely safety reporting in compliance with relevant requirements and maintain the pharmacovigilance (PV) system. You will...

Job Description Job Title: Senior Executive / Specialist - Case Processing Employment Type: Contract Location: Brazil (Remote) About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs,...