Senior Regulatory & Start-Up Specialist, Mexico (Remote)

Precision Medicine Group, LLC.; México; À distance; MXN 900 000 - 1 200 000; Plein temps

Résumé du poste

Precision Medicine Group, LLC. is seeking a Senior Regulatory and Start Up Specialist (RSS) for remote work in Mexico. The role focuses on regulatory submissions, site start-up activities, and coordination with CRA teams to enable timely site activation.

The ideal candidate brings 3.5+ years in regulatory or site start-up within CRO or biotech, and strong English communication. Advanced degrees or RAC certification are a plus.

Qualifications

• Bachelor’s degree in life sciences or RN (or equivalent).
• 3.5+ years as Regulatory or Site Start-Up specialist in CRO/pharma.
• Proficient in English (professional level).

Responsabilités

• Deliver site activation readiness within country/sites, flag risks.
• Prepare Clinical Trial Applications and submission dossiers per local regulations.
• Interact with regulatory authorities and ethics committees; provide timely updates to study leads.
• Maintain project plans, trackers, and regulatory intelligence tools.
• Coordinate with site CRAs to ensure alignment and site collaboration.
• Support budgets and contracts in site start-up processes.
• Translate/coordinate translations for submission documents.
• Maintain TMF readiness and document filing per plans.

Connaissances

Communication

Organizational skills

English proficiency

Prioritization

Formation

Bachelor’s degree in life sciences or RN

Advanced degree in medical or life sciences / RAC

Outils

Milestone tracking tools

Description du poste

Precision Medicine Group, LLC. is seeking a Senior Regulatory and Start Up Specialist (RSS) for remote work in Mexico. The role focuses on regulatory submissions, site start-up activities, and coordination with CRA teams to enable timely site activation.

The ideal candidate brings 3.5+ years in regulatory or site start-up within CRO or biotech, and strong English communication. Advanced degrees or RAC certification are a plus.