Specialist Regulatory Affairs

Position : Specialist Regulatory Affairs

Reporting to : Regulatory Affairs Manager MENA

Division : Abbott Rapid Diagnostic Division

Location : Islamabad – Pakistan

Job Summary :

An experienced Regulatory Affairs professional who operates effectively as an individual contributor under limited supervision. Possesses strong subject matter expertise and applies comprehensive regulatory knowledge to support compliance and business objectives. Demonstrates the ability to assess and address specific regulatory requirements, applying technical skills and professional judgment within the context of unique business needs. Capable of managing responsibilities independently, delivering accurate outcomes, and contributing to regulatory strategies while ensuring adherence to applicable standards and regulations.

Major Responsibilities :

• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills 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
  
  

Education/Knowledge & Experience :

• Preferably Pharm D
• 2 - 3 years’ experience in relevant field
• Teamwork and problem-solving skills