Senior Regulatory and Start Up Specialist (Mexico)

PFM Asset Management

Job Overview

Location

Remote, Mexico

Job Type

Full-time

Full Job Description

📋 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, managing regulatory submissions, and mitigating risks in clinical trial start-up processes.
• Day-to-day responsibilities include preparing and submitting Clinical Trial Application Forms to Competent Authorities and Ethics Committees, reviewing and adapting Informed Consent Forms, maintaining essential documents, coordinating translations, tracking project timelines, and supporting site contract negotiations and budget discussions.
• PFM Asset Management (operating as Precision Medicine Group) is expanding its clinical trial capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, seeking experienced professionals to strengthen regulatory compliance and site start-up excellence in Latin America.
• In this role, you will act as a Subject Matter Expert for in-country teams, mentor junior staff, develop country-specific tools and training materials, and ensure alignment with ICH-GCP, local regulations, and company SOPs while building expertise in global clinical trial operations.

🎯 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 serve as a Subject Matter Expert and mentor junior staff in regulatory and site start-up activities
• Involvement in developing country-specific tools, guidance documents, and training sessions to enhance team knowledge
• Exposure to cross-functional collaboration with Clinical Operations, Project Management, Feasibility, and Site Contracts management

Skills & Technologies

GCP

Senior

Remote

Degree Required

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PFM Asset Management

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About PFM Asset Management

PFM Asset Management is a distinguished investment management firm specializing in providing tailored investment solutions for institutional clients. With a strong focus on fiduciary responsibility and long-term value creation, PFM offers a comprehensive range of services including fixed income, equity, and alternative investment strategies. Their approach is grounded in rigorous research, disciplined risk management, and a deep understanding of client objectives. PFM is committed to transparency and client service, striving to be a trusted partner in helping institutions achieve their financial goals. They serve a diverse clientele, including public funds, corporate pensions, endowments, and foundations, adapting their strategies to meet unique needs.

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