RA Associate - Regulatory Affairs ESA

RA Associate Regulatory Affairs (ESA)

Location: East and Southern Africa

Job Description:

Join our team as an RA Associate where youll support regulatory maintenance activities for our registered base portfolio ensuring optimization and compliance. Youll manage regulatory matters across various spheres of activity such as Registration Production Supply Chain and Quality Assurance. Your role involves engagement with internal and external stakeholders monitoring regulatory requirements and communication of policy intelligence.

Key Responsibilities:

• Support submissions and approvals of quality/CMC variations
  
• Manage life cycle maintenance activities for approved products/variations
  
• Engage and collaborate with internal and external stakeholders
  
• Develop and maintain dashboards and trackers to improve regulatory processes
  
• Monitor and communicate emerging regulatory requirements and policy intelligence
  
• Ensure compliance with global and local/regional processes
  

Requirements

Requirements:

• Education: B.Pharm or life sciences degree or equivalent
  
• Experience: Minimum 13 years experience in pharmaceutical regulatory affairs environment
  
• Languages: Fluency in English as a business language; Portuguese/French is a plus
  
• Computer Skills: Proficiency in MS Office (Excel PowerPoint)
  

• Minimum 13 years experience in pharmaceutical regulatory affairs environment
  
• Knowledge of Regulatory requirements for Medicines in the East and/or Southern Africa countries
  
• A good understanding of pharmacology pharmaceutical and clinical data and the pharmaceutical market
  
• Proficiency in analytical organizational and communication skills
  
• Detailoriented with the ability to prioritize workload and meet deadlines
  
• Proactive peopleorientated with organizational awareness