Regulatory Affairs Executive

Job Description

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