Executive Regulatory Affairs ( Injectables)

Job Title:

Department:

About Jodas Expoim

Jodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation, compliance, and excellence.

Key Responsibilities:

• Prepare, compile, and review registration dossiers (CTD/eCTD formats) for product submissions to ROW/ CIS markets in compliance with local regulatory requirements.
  
• Coordinate with cross-functional teams (Formulation, QA, QC, Production, and RA teams) to gather and verify technical documents for submission.
  
• Manage lifecycle activities including variations, renewals, and responses to regulatory queries.
  
• Track submission timelines and maintain up-to-date records of product registrations and regulatory statuses.
  
• Evaluate country-specific regulatory guidelines and ensure that product dossiers meet those requirements.
  
• Communicate with local agents, distributors, or regulatory consultants in ROW countries for submission planning and updates.
  
• Assist in compiling GMP/WHO-related documents and site registrations as required.
  
• Stay updated with global regulatory changes and proactively support compliance.
  
• Participate in regulatory audits and inspections by supporting documentation and regulatory readiness.
  

Desired Candidate Profile:

• B.Pharm / M.Pharm / M.Sc. in a relevant life science discipline.
  
• 15 years of hands-on experience in regulatory affairs, preferably handling ROW market submissions.
  
• Familiarity with CTD/eCTD structure and requirements.
  
• Good understanding of ICH guidelines and global regulatory frameworks.
  
• Strong verbal and written communication skills in English and Hindi.
  
• Detail-oriented, proactive, and capable of working independently or as part of a team.
  
• Proficient in MS Office (Word, Excel, PowerPoint).

Regards

Team Jodas Expoim PVT LTD