Senior Regulatory and Start Up Specialist (Argentina)

Location: Remote, Argentina

Company

hirify.global provides clinical research and regulatory support for pharmaceutical, biotechnology, and healthcare studies.

What you will do

• Manage initial and subsequent clinical trial submissions to Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies.
• Prepare, review, adapt, translate, and maintain submission documents, informed consent forms, patient information sheets, and essential site documents.
• Coordinate site activation readiness, track milestones and regulatory intelligence, and identify and mitigate risks affecting timelines and quality.
• Interact with regulatory authorities and ethics committees, handle responses, and provide submission and activation status updates to study leadership and project teams.
• Partner with CRAs, Clinical Operations, Feasibility, Project Management, Regulatory, and Site Contracts teams to support site collaboration, budgets, and investigator contracts.
• Act as a subject matter expert, support training and mentoring, maintain audit readiness, and share knowledge of local clinical trial regulations.

Requirements

• Bachelor’s degree in life sciences or a related field, Registered Nurse qualification, or equivalent education, training, and experience.
• At least 3.5 years of experience as a Regulatory or Site Start-Up Specialist in a CRO, pharmaceutical, or biotechnology organization, or equivalent relevant experience.
• Based in Argentina and able to work remotely from Argentina.
• Professional proficiency in English and fluency in Spanish, the local language.
• Knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements, with strong organizational, communication, computer, and prioritization skills.
• Occasional travel may be required.

Nice to have

• Country-specific regulatory and site start-up experience, including feasibility, contract negotiations, and Competent Authority, Ethics Committee, or IRB submissions.
• Experience with milestone tracking tools and supporting junior site start-up specialists.
• Advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.

Culture & Benefits

• Remote work arrangement from Argentina.
• Collaboration with international clinical research and project teams.
• Opportunities to act as a subject matter expert, train colleagues, and contribute to country-specific regulatory knowledge sharing.
• Work involves maintaining audit and inspection readiness and following company SOPs and study-specific plans.