Job Overview
Location
Remote, Mexico
Job Type
Full-time
Category
Operations
Date Posted
April 14, 2026
Full Job Description
đź“‹ Description
- • Senior Regulatory and Start Up Specialist (Mexico) responsible for ensuring timely and high-quality site activation readiness across Mexico and other Latin American countries, including Brazil, Argentina, Colombia, Chile, and Peru, by managing regulatory submissions and compliance with local and international clinical trial standards.
- • Day-to-day duties include preparing and submitting Clinical Trial Application Forms and dossiers to Competent Authorities and Ethics Committees, reviewing and adapting Informed Consent Forms, maintaining essential documents, tracking project timelines, coordinating with cross-functional teams (CRAs, Project Management, Site Contracts), and acting as a Subject Matter Expert for country-specific regulatory processes.
- • Precision Medicine Group is expanding its clinical trial capabilities across Latin America, seeking experienced professionals to support compliant, efficient site start-up activities in alignment with ICH-GCP, local regulations, and company SOPs, with a focus on knowledge sharing and process improvement.
- • In this role, you will deepen your expertise in Latin American clinical trial regulations, lead country-specific regulatory guidance, mentor junior staff, contribute to training development, and gain influence as a trusted advisor in site activation and compliance strategy.
🎯 Requirements
- • Bachelor’s degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience
- • 3.5+ years of experience as a Regulatory or Site Start-Up specialist in a CRO, pharmaceutical, or biotech environment
- • Professional-level English proficiency in both verbal and written communication
🏖️ Benefits
- • Opportunity to act as Subject Matter Expert and mentor for less-experienced staff on site start-up activities
- • Potential to own and develop country-specific tools and guidance documents to increase knowledge sharing
- • Occasional travel may be required, offering exposure to cross-functional collaboration and regional project involvement
Skills & Technologies
About Precision Medicine Group
Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.
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