Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist for a remote position.

Key Responsibilities:

• Direct and coordinate the preparation of regulatory document packages for submissions and audits
• Lead the compilation of materials for license renewal and annual registrations
• Monitor and improve tracking and control systems for regulatory compliance

Required Qualifications:

• Advanced knowledge of regulatory procedures and changes
• Experience in recommending changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
• Ability to interact with regulatory agencies on defined matters
• Experience in recommending strategies for earliest possible approvals of clinical trials applications
• Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience