Principal Regulatory Strategist

Job Summary

A company is looking for a Principal Regulatory Strategist in the CRO/Pharma Industry, working remotely.

Key Responsibilities

• Provide consulting and advisory services for complex regulatory issues or projects
• Author and maintain documentation to sustain regulatory compliance
• Conduct regulatory intelligence gathering to support development of regulatory roadmaps and feasibility assessments

Required Qualifications

• College graduate in Biological Science, Public Health, Regulatory Science, or related field; Masters or PhD preferred
• Minimum of 10 years experience in Regulatory Affairs or Strategy, including experience with Marketing Applications (FDA)
• Expert knowledge of regulatory principles and concepts
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred