Protégé – Regulatory Affairs (12 Months)

Johnson & Johnson Johnson & Johnson · Pharma · Petaling Jaya, Selangor, Malaysia

This role supports the local Regulatory Affairs team in Malaysia, contributing to regulatory activities across assigned product portfolios. The Protégé will develop foundational regulatory knowledge, ensuring compliance with local health authority requirements while supporting timely product registration and lifecycle management.

What you'd actually do

  1. Supporting the preparation and submission of regulatory applications for product registration, renewal, and variations in accordance with local regulatory requirements
  2. Maintaining and updating internal and source company regulatory databases to ensure accuracy and compliance
  3. Liaising with global and regional regulatory teams to obtain required documentation and ensure alignment with Malaysia regulatory requirements
  4. Coordinating with local health authorities by compiling submissions and supporting responses to regulatory queries
  5. Assisting in tracking regulatory timelines and ensuring timely execution of submission plans to support product availability

Skills

Required

  • Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
  • Strong interest in Regulatory Affairs and the pharmaceutical or healthcare industry
  • Strong attention to detail with the ability to manage documentation accurately and systematically
  • Good organisational and time management skills, with the ability to handle multiple tasks and deadlines
  • Effective communication and interpersonal skills to work with cross-functional and global stakeholders
  • Proficiency in Microsoft Office applications and ability to work with databases and documentation systems
  • Proactive learning mindset with a willingness to develop regulatory knowledge and build a long-term career in healthcare

Nice to have

  • Good understanding of basic scientific principles and healthcare product lifecycle is an advantage