Regulatory Specialist 2, Fsp

We are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role! **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...

**Regulatory & Start Up Specialist, c**FSP - US/CAN Support** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site...

**Regulatory & Start Up Specialist, c**FSP.** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site qualification**, site...

**Site Activation Specialist for External Commerce (ComEx) - Homebased** **Essential Functions** - Responsible for importations and exportation activities in Mexico for our FSP model - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site...

**Regulatory Publishing Specialist** The Regulatory Publishing Specialist provides experienced moderate, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in...

Mexico, Remote **Job ID** R0000029006 **Category** Clinical Trials **ABOUT THIS ROLE**: Parexel FSP is looking for a Site Intelligence Specialist in Mexico - The Site Intelligence Specialist (SIS) acts as a supportive team member for Regional Intelligence. Performs tasks for multiple Site Intelligence and Feasibility projects. Works under close...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product...

We are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role! **Location**: Argentina & México **What You´ll Do** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...

**Job Overview** **Essential Functions** - Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases. - Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Purpose**: - Clinical Trial Coordinator - Project Specialist is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - CTC role was...

**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - Acts as liaison with internal stakeholders in the provision of these services. - Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Provides experienced strategic, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for...

Job Overview Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general...

**Job Overview** Perform country-level tasks related to Site Activation (SA) activities at a global scope, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and budgetary guidelines. This role may also involve maintenance activities. **Essential Functions**: - Serve as Single Point of...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...

**ROLE DESCRIPTION** - Lead the compilation and review of technical documents for products spanning food, drugs and cosmetics. This will involve collaboration with regulatory consulting firms, external suppliers, as well as internal functions - Global Regulatory, Global Quality, Global R&D, US Commercial, US Brand, US Supply. - Maintain electronic...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Essential Functions and Other Job Information** - Serves as the primary contact between the sponsor and the organization at the project level. - Ensures escalation pathways adhered to internally and externally (Rules of Engagement - communication pathways). - On projects where...

**The Otte Polo Group is a U.S. based conglomerate of businesses offering tech support, domestic and international contact center, answering services, and 3PL fulfillment solutions. Our brands include Geeks on Site, Responsive Call Center, Phase V Fulfillment, amongst others. We operate from several US offices, and a few in Latin America. We take pride in...