Regulatory & Start Up Specialist 2, cFSP

iqvia; Ciudad de México; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Senior Regulatory & Start Up Specialist, cFSP, to manage end-to-end site activities from feasibility to closure. This role acts as the primary contact for investigative sites and study teams, coordinating regulatory submissions and site activations within Mexico.

The position requires a life sciences or related degree, 3+ years in biopharma/CRO, EC submission experience in Mexico, and strong English and software skills. Remote work from Mexico is supported.

Formación

• Bachelor's degree in Life Science, Business Administration, Finance or related field or work experience equivalent.
• Minimum of three years in biopharmaceutical/CRO industry, including EC submissions in Mexico.
• ICF customization experience.
• Fluent English in written and spoken communication.
• Proficiency with Veeva Vault and Microsoft Office.

Responsabilidades

• Serve as primary site contact for end-to-end study activity for assigned sites/countries.
• Participate in study site management team meetings and provide updates on study and site activity.
• Track activities and generate reports and metrics using systems and tools.
• Oversee essential document collection, tracking and review.
• Support collection of country and site level intelligence.
• Assist with Ethics Committee and Regulatory Authority submissions.
• Assist with country/site-specific activities (e.g., licenses, approvals) to activate or maintain sites.

Conocimientos

Fluent English

Self-starter

Detail oriented

Interpersonal skills

Multi-tasking

Contract negotiation

Educación

Bachelor's degree in Life Science/Business/Finance

Herramientas

Veeva Vault

Microsoft Office

Descripción del empleo

Senior Regulatory & Start Up Specialist, cFSP.

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 regulatory green light and site maintenance/close-outs .

Essential Functions

• Participate in development of in-house model process documents.
• For assigned sites and countries, serve as a primary site contact for end-to-end study activity.
• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
• Oversee essential document collection, tracking & review.
• Support the collection of country and site level intelligence
• Support Ethics Committee and Regulatory Authority submissions
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate or maintain sites for a study as appropriate.

Qualifications

• Bachelor's Degree in Life Science, Business Administration, Finance or related field or work experience equivalent.
• Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, including experience in EC submission in Mexico.
• ICF customization experience.
• Fluent English: written and oral communication skills
• Proficiency with Veeva Vault and all applications of Microsoft Office.
• Ability to negotiate complex contract and payment terms.
• Goal oriented, self-starter with proven ability to work independently.
• Able to proactively identify issues and provide potential solutions for resolution.
• Detail oriented.
• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
• Good interpersonal skills

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.