Regulatory Submission Specialist
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
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