Senior Clinical Trial Regulatory Lead (Hybrid)

Syneos Health, Inc.; Tandil; Hybrid; ARS 123,977,000 - 170,469,000; Full time

Job summary

Syneos Health, Inc. in Argentina/Colombia is seeking a Principal Clinical Trial Regulatory Affairs professional with +4 years of experience managing regulatory submissions across multiple countries.

The role is hybrid, based in Latin America, and focuses on leading strategic regulatory activities related to CTAs and site activation. You will collaborate with cross-functional teams to ensure timely submissions, maintain regulatory plans, and build strong client relationships to support trial

Qualifications

• +4 years of experience in regulatory affairs for clinical trials across multiple countries.
• Experience with regulatory submissions and CTIS workflow is a plus.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead regulatory strategy and submissions for clinical trials across assigned programs.
• Compile core packages, oversee regulatory assessments, and maintain submission timelines.
• Coordinate with Project Manager, sites, and sponsors to address risks and gaps.
• Prepare core regulatory documents and oversee country-specific dossier collation and submissions.
• Mentor and support staff on regulatory processes and quality standards.
• Communicate regulatory status and plans clearly to internal and external stakeholders.

Job description

Syneos Health, Inc. in Argentina/Colombia is seeking a Principal Clinical Trial Regulatory Affairs professional with +4 years of experience managing regulatory submissions across multiple countries.

The role is hybrid, based in Latin America, and focuses on leading strategic regulatory activities related to CTAs and site activation. You will collaborate with cross-functional teams to ensure timely submissions, maintain regulatory plans, and build strong client relationships to support trial