Regulatory Affairs & Compliance

Job Profile:

The Regulatory Affairs & Compliance role ensures that the organization adheres to all relevant regulations, laws, and industry standards. This role involves managing regulatory submissions, ensuring product and process compliance, conducting risk assessments, and maintaining relationships with regulatory bodies.

Regulatory Affairs

• Prepare, review, and submit regulatory documents, reports, and filings to authorities.
  
• Ensure timely approvals for products, services, or operations in compliance with applicable regulations.
  
• Monitor regulatory landscapes and advise management on changes impacting the organization.
  
• Liaise with regulatory authorities for audits, inspections, and inquiries.
  

  
  

  Compliance Management
  

  
  

  Develop, implement, and maintain compliance policies, procedures, and controls.
  

  Conduct internal audits and compliance risk assessments.
  

  Investigate compliance issues, breaches, or violations, and recommend corrective actions.
  

  Ensure staff adherence to ethical standards, organizational policies, and applicable laws.
  

  
  

  Documentation and Reporting
  

  
  

  • Maintain accurate records of regulatory submissions, licenses, and compliance activities.
    
  • Generate regular compliance status reports for senior management and external stakeholders.
    
  • Maintain detailed documentation for audits, inspections, and regulatory filings.
    

    
    

    Training and Awareness
    

    
    

    • Organize and deliver training programs to ensure employees understand regulatory and compliance requirements.
      
    • Promote a culture of compliance and integrity across all levels of the organization.
      

      
      

      Risk Management:
      

      
      

      • Identify and assess compliance risks within the organization.
        
      • Implement risk mitigation strategies and internal controls to address identified risks.
        
      • Conduct compliance audits and investigations, reporting findings to management.