Associate Regulatory Affairs Professional – Near East

About the role

Johnson & Johnson is seeking an Associate Regulatory Affairs Professional to support the Near East regulatory team. The role provides exposure to regulatory strategy, portfolio management, and cross‑functional collaboration across multiple markets.

Key responsibilities

• Act as the regulatory representative for NE countries in therapeutic areas such as Hematology, PAH, and CNS, providing strategic input to CVT and Value Excellence teams.
• Coordinate preparation, review, submission, tracking and follow‑up of regulatory files (new MA dossiers, renewals, variations, MA transfers, distributor changes, etc.) ensuring compliance with local regulations.
• Serve as liaison between local operating companies and international groups, managing dossier exchange, status updates and archiving.
• Maintain electronic and paper tracking systems, regulatory databases and ensure proper archiving of dossiers.
• Provide guidance to internal and external partners, prepare responses to health authority requests, and support importation, NPP and clinical trial applications.

Required profile

• Understanding of business models, strategy drivers and ability to cooperate horizontally with commercial, MAF and other functions.
• Experience acting as regulatory representative on project teams and contributing to project plans and target product profiles.
• Ability to ensure compliance with local laws, HCBI guidelines, FCPA and company policies.

Required skills

• Regulatory submission preparation and management.
• Regulatory database and tracking system usage.
• Knowledge of local regulatory requirements for marketing authorisations and promotional material.