Regulatory Affairs Specialist

**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,...

In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico. **Responsibilities**: Assisting with the preparation of LATAM Marketing Authorization Applications Preparation and submission of documentation for post-authorization activities Compile Dossier as per country requirements Education &...

An Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. An Associate must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and Supervisor, taking...

Act as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising. - Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics. - Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and...

**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 guidelines. May also include maintenance activities. **Essential Functions** - Under general supervision,...

Supports the preparation of documentation and submissions under guidance - Coordinates and manages client deliverables supporting regulatory compliance - Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects - Assists with project budgeting/forecasting - Maintains knowledge and...

Summarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...

**Project** Description**: Luxoft DXC Technology Company is an established company focusing on consulting and implementation of complex projects in the financial industry. At the interface between technology and business, we convince with our know-how, well-founded methodology and pleasure in success. As a reliable partner to our renowned customers, we...

IQVIA Biotech, a global full service CRO providing flexible and tailored clinical solutions to smaller biotech companies, is seeking additional talent within our **Site File Operations team**. Our **Site File Specialist II **opportunity requires: BS/BA/BSc, or equivalent, plus 2 years of related experience; regulatory document review experience preferred....

**Job Overview** Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...

Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. -...

**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...

**_IQVIA Biotech is seeking a Safety Specialist located in Mexico (Home Based) with prior CRO experience and a minimum of two years in clinical trial safety processing in Argus:_** **BASIC FUNCTION**: - Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific...

Job Overview Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...

Receives, prepares, and submits safety reports to applicable parties. Escalates to lead and line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts the manager to quality or timeline issues. Participates in project teams and may lead...

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 guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

**_IQVIA Biotech _**_is seeking a Clinical Safety Specialist with at least 2 years of clinical trial case processing experience working in Argus:_ **BASIC FUNCTION**: - Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures. - Primary responsibilities...

Paired is a global staffing and recruiting agency that pairs remote work with top-tier talent. We help individuals from around the world connect with great companies that are looking for their specific skill set. Our mission is to provide great jobs to talented people, no matter where they are located. Our client is a leading US-based insurance company, and...

Job Overview Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements. Essential Functions - Develop Coordinate the development of investigator grants and estimates, contracting strategies and...

**Remote Construction Estimator / Material Takeoff Specialist** **Green Attic Insulation** **Remote (USA-based)** **About Us**: Green Attic Insulation is a leading roofing and insulation company specializing in energy-efficient solutions. With our commitment to quality and customer satisfaction, we have built a strong reputation in the industry. Our...