Regulatory Submission Specialist

Job Summary

A company is looking for a Regulatory Submission Specialist to join their regulatory team remotely.

Key Responsibilities

• Develops and maintains knowledge of global and local regulatory requirements for submission activities
• Manages adaptation of master documentation for submission to local requirements and oversees obtaining necessary approvals
• Maintains tracking of regulatory, ethics, and administrative submission and approval dates

Required Qualifications

• Minimum 2 years' experience in a pharmaceutical or Clinical Research Organization
• Experience with CA and CEC submission processes
• Knowledge of ICH / GCP regulations and IRB
• Experience with contracts and budget negotiation
• Fluent in English