Start-up & Regulatory Specialist

**Description** **Job Description**: JOB TITLE: Site Start-Up & Regulatory Specialist II SELECT ONE: Clinical Solutions JOB CODE: 01022 REPORTS TO: Manager, Site Start-Up & Regulatory; or designee JOB SUMMARY Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for...

**JOB DESCRIPTION** **PURPOSE** Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification...

The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...

**Regulatory Affairs Specialist** **Major Tasks** - Provides operational support to Regulatory Affairs Management in active projects such as local regulatory strategy for New Drug Applications, local preparation for the New Molecules Committee and other projects. - Propose the local regulatory strategy for maintenance projects of the active registrations by...

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...

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,...

In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. 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 (sites and medicinal...

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...

**Requisition Number**7930** **Employment Type**:Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and...

**Description** **Site Start-Up & Regulatory Specialist I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value...

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...

Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory compliance for assigned product lines Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents...

**About Kerry**: - Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of...

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...

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;...

Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion,...

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.- Coordinates, under guidance, with...

About Kerry Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to create healthier, tastier and more sustainable products that are consumed by billions of people across the world. Our vision is to be our customers' most valued partner, creating a world of...

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the centre of all that we do, we help to accelerate the development...

Job Description 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. Coordinates, under guidance,...