Senior Regulatory And Start Up Specialist (Medical)

TL;DR

Senior Regulatory And Start Up Specialist (Medical): Managing regulatory submissions and site start-up activities for clinical trials with an accent on CA/EC submissions and essential document collection. Focus on ensuring timeliness of site activation and compliance with local and international ICH-GCP regulations.

Location: Remote, Mexico

Company

hirify.global provides comprehensive clinical research services to support the development of precision medicines.

What you will do

• Lead initial and subsequent clinical trial submissions to Competent Authorities (CA) and IRB/Ethics Committees.
• Manage the collection and quality review of essential documents for site activation and IMP release.
• Act as a Subject Matter Expert (SME) for in-country site start-up activities and mentor junior staff.
• Customize Patient Information Sheets and Informed Consent Forms for local sites.
• Coordinate with CRAs, Project Managers, and Site Contract Management for budget and contract negotiations.
• Maintain audit/inspection readiness and manage TMF documentation according to study plans.

Requirements

• Bachelor's degree in life sciences, healthcare, or Registered Nurse (RN) equivalent.
• 3.5+ years of experience as a Regulatory or Start-Up specialist in CRO or pharmaceutical/biotech industry.
• Professional proficiency in English and fluency in the local language of Mexico.
• Deep knowledge of ICH-GCP guidelines and local clinical trial laws/regulations.
• Strong organizational skills and ability to prioritize workload in a fast-paced environment.
• Must be based in Mexico.

Nice to have

• Advanced degree in medical or life sciences (MD, PhD, PharmD) or RAC certification.
• Experience using milestone tracking tools and systems.
• Proven ability to assist junior specialists in problem resolution.

Culture & Benefits

• Fully remote work arrangement within Mexico.
• Opportunity to work with an expanding international team across the LATAM region.
• Professional growth within a specialized clinical research organization.
• Inclusive work environment adhering to Equal Opportunity Employer principles.