REGULATORY AFFAIRS MANAGER - ARGENTINA AND COLOMBIA

Main Purpose of the Role

Manages teams within the Regulatory Affairs Sub-Function.

Focus is on policy and strategy implementation and control rather than development.

Typically handles short-term operational/tactical responsibilities.

• Main Responsibilities As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following : product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
  
  

Qualification

Education

Associates Degree (± 13 years)

Experience / Background

Minimum 7 years