Regulatory Affairs Executive - Senior Executive -CIS Markets

Key Responsibilities:

Dossier Preparation & Compilation

• Compile, review, and format regulatory dossiers as per

  CIS market (Kazakhstan, Uzbekistan, Russia, Georgia, Armenia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan)

  requirements.
• Prepare Modules 15 including administrative, quality (CMC), non-clinical, and clinical sections.
  
• Ensure accurate and compliant documentation for product registration and renewals.
  

Regulatory Submissions

• Coordinate with internal teams (R&D, QC, QA, Production, Packaging, etc.) to gather required documents.
  
• Prepare, submit, and track registration applications, variations, and renewals for

  CIS countries (Kazakhstan, Uzbekistan, Russia, Georgia, Armenia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan)

  .
• Support lifecycle management activities including post-approval changes.
  

Regulatory Compliance & Guidelines

• Ensure dossiers meet the regulatory standards of

  CIS authorities (Kazakhstan, Uzbekistan, Russia, Georgia, Armenia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan)

  .
• Stay updated on changing regulatory guidelines and communicate relevant changes to stakeholders.
  
• Support in preparing responses to regulatory queries.
  

Documentation & Data Management

• Maintain regulatory databases, submission trackers, and documentation repositories.
  
• Review artwork, labeling, and packaging information for compliance with

  CIS-specific (Kazakhstan, Uzbekistan, Russia, Georgia, Armenia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan)

  requirements.
• Ensure proper archival and retrieval of regulatory submissions.
  

Stakeholder Coordination

• Liaise with local agents, distributors, and regulatory bodies in

  CIS markets (Kazakhstan, Uzbekistan, Russia, Georgia, Armenia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan)

  as needed.
• Collaborate with internal teams for timely submission and approval of dossiers.
  

Skills & Competencies Required:

• Strong knowledge of

  CIS regulatory guidelines (Kazakhstan, Uzbekistan, Russia, Georgia, Armenia, Azerbaijan, Kyrgyzstan, Tajikistan, Turkmenistan)

  .
• Hands-on experience in compiling Modules 1–5.
  
• Strong communication, documentation, and coordination skills.