We are searching for the best talent for Protégé – Regulatory Affairs

Purpose:

The Protégé – Regulatory Affairs will support the local Regulatory Affairs team in Malaysia, contributing to regulatory activities across assigned product portfolios.

This role provides a structured learning experience to develop foundational regulatory knowledge, ensuring compliance with local health authority requirements while supporting timely product registration and lifecycle management.

You will be responsible for:

• Supporting the preparation and submission of regulatory applications for product registration, renewal, and variations in accordance with local regulatory requirements
• Maintaining and updating internal and source company regulatory databases to ensure accuracy and compliance
• Liaising with global and regional regulatory teams to obtain required documentation and ensure alignment with Malaysia regulatory requirements
• Coordinating with local health authorities by compiling submissions and supporting responses to regulatory queries
• Assisting in tracking regulatory timelines and ensuring timely execution of submission plans to support product availability
• Participating in cross-functional discussions to understand business needs and align regulatory strategies accordingly
• Contributing to team meetings, sharing learnings, and gaining exposure to regulatory best practices and processes
• Supporting ad hoc regulatory activities and projects as assigned by the Regulatory Affairs Manager

Qualifications / Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline
• Strong interest in Regulatory Affairs and the pharmaceutical or healthcare industry
• Good understanding of basic scientific principles and healthcare product lifecycle is an advantage
• 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

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Across our therapeutic areas, we are committed to transforming patient outcomes by bringing innovative treatments to those who need them most, while ensuring quality, safety, and compliance at every step of the product lifecycle.

Your unique talents will help patients on their journey to wellness while building a strong foundation for a career in healthcare.