Senior Regulatory & Start-Up Specialist – Mexico

precisionmedicinegroup; México; Presencial; MXN 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Precision for Medicine is expanding across Mexico and Latin America and seeks a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico. You will oversee regulatory submissions, site activation activities, essential document management, and ensure compliance with local and international trial regulations.

As a seasoned professional, you will train staff, support budget/contract negotiation with Site Contract Management, and collaborate with cross-functional teams to drive efficient

Formación

• Bachelor's degree in life sciences or related field.
• Experience in regulatory submissions and site start-up is a plus.

Responsabilidades

• Delivery of site activation readiness within the assigned country/sites, ensuring timely and quality results.
• Prepare Clinical Trial Application Forms and submission dossiers for CA, EC, and local bodies within required timelines.
• Interact with CA/EC and provide timely responses and updates to stakeholders.
• Maintain project plans, trackers, and regulatory intelligence tools and keep Regulatory Leadership informed.
• Support development of country start-up plans, IMP release requirements, and essential document review.
• Partner with site CRA to align communications and secure site collaboration.
• Translate and coordinate translations for submission documents as needed.
• Maintain knowledge of local trial laws and ensure compliance with international and local regulations.
• Maintain TMF readiness and file documents per TMF plans.

Educación

Bachelor's degree in life sciences or related field

Descripción del empleo

Precision for Medicine is expanding across Mexico and Latin America and seeks a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico. You will oversee regulatory submissions, site activation activities, essential document management, and ensure compliance with local and international trial regulations.

As a seasoned professional, you will train staff, support budget/contract negotiation with Site Contract Management, and collaborate with cross-functional teams to drive efficient