Senior Regulatory Consultant- Lead
ClinChoiceNew York, New York, United States
Posted August 27, 2025
Full Time
About the Company
ClinChoice is a leading global full-service CRO with three decades of experience in pharmaceutical, biotechnology, medical device, and consumer health sectors. Specializing in clinical development, post-marketing and real-world evidence, quality and compliance, and technology solutions, ClinChoice offers comprehensive support worldwide with its deep regulatory expertise, robust pharmacovigilance, and project management capabilities.
Job Description
This Senior Regulatory Consultant- Lead role focuses on ensuring product compliance with Ministry of Health regulations in Mexico. The role involves creating regulatory strategies, supporting team formation, leading consultants to deliver high-quality submissions, and coordinating regulatory documents. It requires strong communication, coordination, and understanding of local regulations.
Requirements
- Creation of regulatory strategies with the client regulatory team
- Support in the creation of a high-performance team
- Preparation and compilation of regulatory submissions
- Research and coordination of export certificates
- Support of CMC dossier preparation and review
- Review of artwork and change controls
- Monitoring of regulatory standards
- Coordination of label change initiation
