Senior Global Regulatory Strategist, Clinical Trials

Syneos Health Clinical; Buenos Aires; Sur place; ARS 139 364 000 - 185 819 000; Plein temps

Résumé du poste

Syneos Health Clinical in Buenos Aires seeks a Senior Clinical Trial Regulatory Advisor to lead country and regional submissions across multiple markets. You will coordinate regulatory activities, compile core packages, and maintain relationships with regulators and sponsors.

The role requires deep knowledge of GxP, EU/ECA/Latin America regulations, and strong project management skills to ensure timelines and quality across the study lifecycle.

Qualifications

• Requires strong regulatory knowledge across multiple markets.
• Experience with regulatory strategy and submissions management.
• Excellent communication and stakeholder management skills.

Responsabilités

• Lead regulatory strategy and submission planning for country/regional programs.
• Coordinate preparation of submission dossiers and regulatory documents.
• Engage regulators and sponsor teams to mitigate risks and ensure timeliness.

Connaissances

Regulatory leadership

CTIS submissions

Cross-country submissions

GxP knowledge

Formation

Bachelor’s Degree in Life Sciences

Outils

CTIS portal

Description du poste

Syneos Health Clinical in Buenos Aires seeks a Senior Clinical Trial Regulatory Advisor to lead country and regional submissions across multiple markets. You will coordinate regulatory activities, compile core packages, and maintain relationships with regulators and sponsors.

The role requires deep knowledge of GxP, EU/ECA/Latin America regulations, and strong project management skills to ensure timelines and quality across the study lifecycle.