The Principal Specialist Regulatory Affairs role involves applying comprehensive strategic knowledge of regulatory frameworks to develop and align global regulatory strategies with organizational goals
Job Summary
The Principal Specialist Regulatory Affairs role involves applying comprehensive strategic knowledge of regulatory frameworks to develop and align global regulatory strategies with organizational goals.
This position requires managing complex negotiations with regulatory authorities and providing guidance on regulatory pathways to expedite product development, especially for serious or life-threatening medical conditions.
The role supports organizational compliance by developing training programs, managing regulatory submissions, and preparing cross-functional teams for regulatory interactions.
Matching Summary
The Principal Specialist Regulatory Affairs role involves applying comprehensive strategic knowledge of regulatory frameworks to develop and align global regulatory strategies with organizational goals.
Skills & Requirements
Must-have
Global regulatory strategy development
Regulatory submissions management
Negotiations with regulatory authorities
Regulatory risk assessment and mitigation
Market access and distribution compliance
Regulatory pathway analysis
Hybrid work flexibility
Nice-to-have
Strategic advocacy participation
Cross-functional team leadership
Staff coaching and mentoring
Cultural sensitivity in communication
Adaptability to regulatory changes
Advanced regulatory science knowledge
Key Requirements
Minimum 9 years regulatory affairs experience
BS in Engineering, Science or related field
MS or advanced degree in Regulatory Science desired