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 client is seeking their first Senior Regulatory and Start Up Specialist based in Argentina to lead clinical trial submissions, site activation, and compliance activities across the region.

In this role, you will serve as a subject matter expert for regulatory submissions to Competent Authorities and Ethics Committees, manage essential document collection, and support site contract negotiations. You will work cross-functionally with clinical operations, project management, and feasibility teams to ensure timely site activation while maintaining compliance with local and international clinical trial regulations.

Responsibilities

• Prepare and submit clinical trial applications and dossiers (initial and amendments) to Competent Authorities, Ethics Committees, and other local regulatory bodies within required timelines
• Manage interactions with regulatory authorities and Ethics Committees, including handling responses and queries
• Ensure delivery of site activation readiness within assigned country and sites, identifying and mitigating risks
• Customize country-specific Patient Information Sheets and Informed Consent Forms; coordinate translations as needed
• Collect, review, and manage essential documents required for site activation and investigational product release
• Partner with Clinical Research Associates to ensure alignment in site communication and collaboration
• Maintain project plans, regulatory trackers, and regulatory intelligence tools; provide regular status updates to leadership and project teams
• Support budget and contract negotiation activities under direction of Site Contract Management
• Act as subject matter expert on local regulatory timelines, Ethics Committee processes, and site activation requirements
• Maintain audit/inspection readiness and ensure proper document filing per Trial Master File requirements
• Stay current on local clinical trial laws and regulations; distribute knowledge internally to ensure compliance
• Mentor less-experienced staff on regulatory submissions and local start-up procedures
• May participate in pre-study site visits, feasibility outreach, and client presentations

What We're Looking For

Required qualifications:

• Bachelor's degree in life sciences or related field (ideally scientific or healthcare discipline), Registered Nurse, 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 proficiency (written and verbal)
• Fluency in Spanish and English
• Strong knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Excellent organizational and communication skills
• Experience with computerized information systems, electronic spreadsheets, word processing, and email
• Ability to prioritize workload and meet tight deadlines in a fast-paced environment
• Attention to detail with emphasis on accuracy
• Ability to work independently with minimal supervision

Preferred qualifications:

• Direct regulatory and site start-up experience in Argentina (feasibility, contract negotiations, regulatory submissions)
• Experience using milestone tracking tools and systems
• Ability to assist junior specialists in problem resolution
• Advanced degree (MD, PhD, PharmD), RAC certification, or Master's in Regulatory Science
• Flexibility for occasional travel

How We Work With You

Get A Job.ai specializes in connecting qualified professionals with leading organizations in clinical research and life sciences. When you apply through our platform, our talent team will conduct an initial screening to understand your background and career goals. If there is a strong match, we will submit your profile to our client for consideration. We manage the coordination throughout the interview process and provide guidance on next steps.

Please apply exclusively through Get A Job.ai. Do not attempt to contact the client organization directly, as all applications must be submitted through our recruiting process to be considered.

Pay

Compensation details will be discussed during the screening process based on experience and qualifications.

Get A Job.ai is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all candidates and employees.