Title: Executive Regulatory Affairs (Africa & LATAM Regions)

Location : Mumbai

Required Modules: CTD Modules 1, 2, 3, 4 & 5

Job Purpose

To manage regulatory documentation, dossier preparation and submission activities for biological products across African and Latin American (LATAM) markets, ensuring compliance with regional regulatory guidelines and requirements.

Key Responsibilities

- Prepare, review and compile regulatory dossiers for biological products covering CTD Modules 15.
- Handle clinical, non-clinical, quality and administrative regulatory documentation.
- Manage product registration, renewals, variations and regulatory submissions across African and LATAM markets.
- Ensure compliance with country-specific regulatory guidelines and submission requirements.
- Coordinate audit-related documentation and maintain regulatory records.




- Monitor regulatory updates and support responses to queries from health authorities.
- Collaborate with QA, QC, R&D;, Clinical and Manufacturing teams for regulatory documentation and submissions.

Key Requirements

- Experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Exposure to biological products, vaccines or biosimilars.
- Knowledge of regulatory requirements for African and LATAM markets.
- Hands-on experience in CTD dossier preparation, review and compilation.
- Understanding of CTD Modules 1, 2, 3, 4 and 5.
- Experience in clinical/non-clinical documentation, quality dossiers and regulatory submissions.
- Knowledge of audit documentation, product registration and regulatory compliance.

📌 Regulatory Affairs Associate (Mumbai)
🏢 Selective Global Search
📍 Mumbai