Regulatory & Start Up Specialist, cFSP

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 level...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

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...

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,...

RSU Specialist for External Commerce (ComEx) Location: LATAM Essential Functions • Responsible for importations and exportation activities in specific LATAM countries for our FSP model. • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. • Perform start...

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,...

The Opportunity We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the...

In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Group 10 Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration...

In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Group 10 Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

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. Essential Functions Pharmacovigilance processes applicable to RSU. Submission of safety reports (periodic and...

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in other related areas. - As member of the Regulatory Submissions team, you will contribute to at least one of the following activities: - Preparation,...

The Regulatory Risk Sr Officer II is a strategic professional who closely follows latest trends in own field and adapts them for application within own job and the business. Recognized subject matter expert within one area. Strong commercial awareness is a necessity. Is an acknowledged authority both within and outside area of expertise. Typically a small...

The Regulatory Risk Sr Officer II is a strategic professional who closely follows latest trends in own field and adapts them for application within own job and the business. Recognized subject matter expert within one area. Strong commercial awareness is a necessity. Is an acknowledged authority both within and outside area of expertise. Typically a small...

The Regulatory Risk Sr Officer II is a strategic professional who closely follows latest trends in own field and adapts them for application within own job and the business. Recognized subject matter expert within one area. Strong commercial awareness is a necessity. Is an acknowledged authority both within and outside area of expertise. Typically a small...

Description : The Regulatory Advisor is responsible for providing support to implement and execute oversight for Mexico Regulatory Reporting Ownership Procedure (RROP) adequate implementation, where the In-Business Risk and Control will identify the data lineage of new and unowned regulatory reports, and set roles and responsibilities for regulatory...

Description : The Regulatory Advisor is responsible for providing support to implement and execute oversight for Mexico Regulatory Reporting Ownership Procedure (RROP) adequate implementation, where the In-Business Risk and Control will identify the data lineage of new and unowned regulatory reports, and set roles and responsibilities for regulatory...