Site Activation & Regulatory Specialist I

IQVIA; Ciudad de México; On-site; MXN 350,000 - 450,000; Full time

Job summary

IQVIA is seeking a Regulatory & Start Up Specialist 1, cFSP, to manage country-level Site Activation activities and regulatory document preparation. You will work with the SAM, PM team, and sites to ensure compliance with SOPs, timelines, and quality standards.

The role requires a life sciences background, startup and clinical research experience, and fluent English. Strong analytical skills and the ability to manage multiple priorities in a fast-paced environment are essential.

Qualifications

• Bachelor degree in life sciences.
• +1 year of clinical research experience and startup management.
• Fluent English (written and spoken).
• Strong analytical and critical thinking.
• Excellent interpersonal and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Serve as Single Point of Contact (SPOC) for investigative sites, SAM, PM team, and other departments.
• Perform startup and site activation activities per regulations and SOPs; distribute docs to sites and team.
• Prepare site regulatory documents, review for completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with project data.
• Review and provide feedback on site performance metrics.
• Establish and agree on project timelines; ensure monitoring measures and contingency plans.
• Inform team of regulatory/contractual document completion.
• Track and follow up on approval and execution of regulatory docs per timelines.
• Provide local regulatory expertise during project planning.
• Quality control documents provided by sites.
• May contact sponsors on specific initiatives.

Skills

Life sciences background

Fluent English

Analytical thinking

Interpersonal skills

Multitasking

Education

Bachelor's degree in life sciences

Job description

IQVIA is seeking a Regulatory & Start Up Specialist 1, cFSP, to manage country-level Site Activation activities and regulatory document preparation. You will work with the SAM, PM team, and sites to ensure compliance with SOPs, timelines, and quality standards.

The role requires a life sciences background, startup and clinical research experience, and fluent English. Strong analytical skills and the ability to manage multiple priorities in a fast-paced environment are essential.