Senior Regulatory & Site Start-Up Lead – LATAM

Pfm; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Remote work

Job summary

Precision Medicine Group is expanding its regulatory capabilities across Latin America and is hiring its first Senior Regulatory and Start Up Specialist (Senior RSS) in Argentina. You will drive site activation readiness, prepare CTAs and submission dossiers for CA/EC, and collaborate with CROs and internal teams to ensure compliance with ICH-GCP and local regulations.

The role requires strong English communication, regulatory start-up experience, and the ability to mentor junior staff while

Qualifications

• Bachelor’s degree in life sciences or related field or RN or equivalent
• 3.5+ years as Regulatory or Start-Up specialist in CRO/pharma/biotech
• Strong English written and spoken communication

Responsibilities

• Deliver site activation readiness on time with quality
• Prepare Clinical Trial Applications and dossiers for CA/EC submissions
• Interact with CA/EC and provide updates to study team
• Maintain regulatory trackers and country start-up plans
• Mentor staff on local start-up regulations and processes

Skills

Regulatory expertise

Site start-up

Clinical trials

English proficiency

Education

Bachelor's in life sciences

RAC certification

Tools

CTMS

eTMF

Job description

Precision Medicine Group is expanding its regulatory capabilities across Latin America and is hiring its first Senior Regulatory and Start Up Specialist (Senior RSS) in Argentina. You will drive site activation readiness, prepare CTAs and submission dossiers for CA/EC, and collaborate with CROs and internal teams to ensure compliance with ICH-GCP and local regulations.

The role requires strong English communication, regulatory start-up experience, and the ability to mentor junior staff while