Senior Regulatory and Start Up Specialist (Argentina)

About This Opportunity

We are representing a confidential clinical research organization expanding its regulatory capabilities across Latin America. Our talent team is searching for a Senior Regulatory and Start Up Specialist based in Argentina to lead critical site activation and submission activities for clinical trials.

This is a senior-level role requiring deep expertise in regulatory submissions to Competent Authorities and Ethics Committees, informed consent adaptation, essential document management, and collaboration with site contract teams on budget and contract negotiation.

Responsibilities

• Prepare and submit Clinical Trial Applications and dossiers (initial and amendments) to Competent Authorities, Ethics Committees, and other local regulatory bodies in compliance with ICH-GCP and local regulations
• Manage all interactions with regulatory authorities and Ethics Committees, including handling responses and queries
• Ensure timely and quality delivery of site activation readiness within assigned country/sites, identifying and mitigating risks
• Customize country and site-specific Patient Information Sheets and Informed Consent Forms
• Prepare, review, and collect essential documents required for site activation and investigational medicinal product release
• Partner with assigned site CRAs to align communication and secure site collaboration
• Coordinate translations for submission documents as required
• Act as Subject Matter Expert for in-country team members on regulatory and start-up activities
• Support development of study-specific start-up plans and essential document review criteria
• Participate in or support budget negotiation and investigator contract execution as directed
• Maintain project trackers, regulatory intelligence tools, and Trial Master File documentation in audit-ready condition
• Provide regular status updates to Start Up Leads, Regulatory Leads, and Project Management teams
• May mentor junior staff on local regulations, submissions, and internal procedures
• May support feasibility activities, pre-study site visits, and client presentations

What We're Looking For

Required:

• Bachelor's degree in life sciences, healthcare, or related field (or Registered Nurse qualification), or equivalent combination of education and experience
• 3.5+ years as a Regulatory or Start Up Specialist in a CRO, pharmaceutical, or biotech environment
• Professional-level English fluency, both written and verbal
• Fluency in Spanish (local language requirement for Argentina-based position)
• Strong knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements
• Excellent organizational skills with ability to prioritize workload and meet strict deadlines
• Experience with computerized information systems, electronic spreadsheets, word processing, and email
• Ability to work independently in a fast-paced environment with attention to detail and accuracy

Preferred:

• Argentina-specific regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions)
• Experience using milestone tracking tools and systems
• Advanced degree (MD, PhD, PharmD), RAC certification, or Master's in Regulatory Science
• Experience assisting junior specialists in problem resolution
• Strong presentation and interpersonal skills with ability to inform, influence, and persuade stakeholders

Occasional travel may be required.

How We Work With You

Candidates apply directly through Get A Job.ai. Our recruiting team will screen qualified applicants and coordinate interviews with our client. We will submit your profile to the client on your behalf and guide you through each stage of the process. Please do not contact the client directly during the recruitment process.

Pay

Compensation details will be discussed with qualified candidates during the screening process.

Equal Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applications from all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, or veteran status.