Senior Regulatory & Start-Up Lead (Mexico)

Precision Medicine Group; Mexico; Remote; MXN 600,000 - 900,000; Full time

Job summary

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist for Mexico, with remote work options in the country. The role focuses on regulatory submissions, site activation, and collaboration with local authorities and ethics committees to ensure timely approvals for clinical trials.

The Senior RSS may mentor staff, develop country-specific tools, and maintain project plans while ensuring compliance with ICH-GCP and local regulations.

Qualifications

• Bachelor's degree in life sciences or RN or equivalent.
• 3.5+ years as Regulatory or SU specialist in CRO or pharma.
• Professional English communication required.

Responsibilities

• Deliver site activation readiness within the assigned country and sites.
• Prepare Clinical Trial Applications and submission dossiers per local rules.
• Interact with authorities and ethics committees; track responses.

Skills

Regulatory start-up

Site activation

English proficiency

Education

Bachelor's degree in life sciences

Registered Nurse (RN)

Tools

Milestone tracking tools

Job description

Precision Medicine Group is seeking a Senior Regulatory and Start Up Specialist for Mexico, with remote work options in the country. The role focuses on regulatory submissions, site activation, and collaboration with local authorities and ethics committees to ensure timely approvals for clinical trials.

The Senior RSS may mentor staff, develop country-specific tools, and maintain project plans while ensuring compliance with ICH-GCP and local regulations.