ANALISTA SENIOR DE ASUNTOS REGULATORIOS

Regulatory Affairs Specialist 4

Level Description
Professional’ Leveling Guide consists of jobs with a professional nature that require “learned knowledge” most often attained through advanced education and experience. This can include business and/or clinical professionals.

Market Summary
Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Ensures that privacy and security standards are met and adhered to. Recommends strategies for earliest possible approvals of clinical trials applications. Assists with the corrective action implementation.

Impact
• Applies advanced subject matter expertise in job area typically obtained through advanced education and work experience.
• Make decisions on complex issues and ambiguous matters, and provides direction regarding approach and priorities.

Communication
• Interacts with internal stakeholders, including global, regional and national management as well as external stakeholders which may include clients and customers.
• Solutions require consideration of impact on operational and financial dimensions of the business.

Innovation
• Improves existing methods, techniques and/or processes across job areas.
• Problems and issues faced are, in general, difficult and often complex.

Knowledge
• Under general direction, works on extremely complex matters and assignments of large scope, impact, and importance, where business acumen, leadership and /or ingenuity are required.
• Typically requires:
- a bachelor's degree and 8-12+ years of experience
- a master's degree and 6+ years of experience