Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation
Job Summary
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.
The Associate RA Manager will be responsible for new product registration, CMC variations, label updates, clinical trial applications, and supporting regulatory activities in license management.
The role involves collaboration with multiple internal departments and external regulatory bodies to ensure timely and compliant submissions.
Matching Summary
Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured through healthcare innovation.
Skills & Requirements
Must-have
New product registration
Regulatory dossier review and submission
Knowledge of local regulatory requirements
Label updates and clinical trial applications
Regulatory license management support
Communication with internal and external stakeholders
Nice-to-have
Interpersonal communication skills
Negotiation abilities
Awareness of drug development principles
Fluency in English and local language
Familiarity with SOP development
Knowledge of Janssen Korea products
Key Requirements
Bachelor degree in pharmacy or healthcare equivalent
5 to 7+ years regulatory affairs experience
Knowledge of local and global regulatory standards
Fluency in English and local language
Training in Johnson & Johnson requirements and local SOPs