Regulatory Affairs Executive

Knowledge of registration requirements and procedures in LATAM (e.g., Brazil, Mexico, Argentina, Colombia, Peru, Chile) and other ROW countries (e.g., Africa, CIS, Southeast Asia).

• Experience with dossier preparation in CTD/ACTD/non-CTD formats.
• Familiarity with country-specific labeling, packaging.
• Strong communication, coordination, and documentation skills.
• Proficient in MS Office, document management tools, and regulatory tracking systems.

• Dossier Preparation: Compile, review, and submit registration dossiers (CTD/eCTD formats) for domestic and export markets (e.g., ROW, semi-regulated, and regulated markets).
  
• Regulatory Submissions: Handle regulatory filings for new product approvals, renewals, variations, and lifecycle maintenance.
  
• Labeling & Packaging Compliance: Ensure that product labeling, artwork, and packaging components comply with the regulatory requirements of respective authorities.
  
• Communication: Coordinate with R&D, QA, QC, Production, and external partners to gather necessary documents for submissions.
  
• Regulatory Intelligence: Monitor and interpret global regulatory requirements and communicate relevant updates to internal stakeholders.
  
• Audit Support: Assist in preparation and support during audits and inspections by regulatory authorities.
  
• Documentation: Maintain regulatory records, track submission timelines, and ensure completeness and accuracy of submitted documentation.
  
• Product Registrations: Liaise with international clients and agents for timely product registration and license renewals.
  
• Compliance: Ensure all activities comply with applicable guidelines (CDSCO, USFDA, EU, WHO-GMP, etc.).Role & responsibilities

Preferred candidate profile