Manager - Registration Management

MAIN PURPOSE OF ROLE

• Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs.

  
  
  

• Ability to execute highly complex or specialized projects.

  
  
  

• Adapts precedent and may make significant departures from traditional approaches to develop solutions.

  
  
  

MAIN RESPONSIBILITIES

• As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in 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.

  
  
  

QUALIFICATIONS

Education

• Associates Degree (±13 years)

  
  
  

Experience/Background

• Minimum 7 years