Drug Regulatory Affairs Executive

Role & responsibilities

Job Summary:

Senior Executive Drug Regulatory Affairs

Key Responsibilities:

• Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/non-CTD formats) for injectable products in ROW markets (e.g., Latin America, Africa, CIS, Southeast Asia, Middle East).
  
• Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Packaging) to gather required technical documentation.
  
• Ensure all submissions comply with the local regulatory requirements of target countries.
  
• Liaise with in-country agents, partners, and regulatory consultants to facilitate product registrations and respond to queries from local health authorities.
  
• Maintain a tracker/database of ongoing submissions, approvals, and renewals.
  
• Prepare and submit post-approval changes, renewals, variations, and labeling updates as required.
  
• Keep abreast of regulatory changes in ROW regions and update internal stakeholders accordingly.
  
• Support in preparation of dossiers for WHO prequalification and other international tenders, where applicable.
  
• Assist in audits, inspections, and regulatory due diligence activities.
  

Qualifications & Experience:

• Education:

  B.Pharm / M.Pharm / M.Sc. in Regulatory Affairs, Pharmaceutical Sciences, or related discipline.

• Experience:

  3–7 years of relevant regulatory experience in injectable dosage forms for ROW markets.

• Knowledge:

• Strong understanding of regulatory frameworks in key ROW regions.
  
• Familiarity with CTD, ACTD, and country-specific dossier formats.
  
• Understanding of injectable-specific regulatory and GMP requirements.
  

• Skills:

• Excellent communication and coordination abilities.
  
• Good documentation and technical writing skills.
  
• Ability to work independently and handle multiple projects simultaneously.
  

Preferred Qualifications:

• Experience in handling injectable dossiers for semi-regulated markets such as Latin America, Africa, CIS, or Southeast Asia.
  
• Familiarity with WHO prequalification processes.
  
• Hands-on experience with lifecycle management including variations, renewals, and post-approval changes.