Protégé - Regulatory Affairs

5w1 month ago

Johnson & Johnson

MY · Part-time · MYR 30,000 – MYR 45,000

About this role

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.

Day-to-day responsibilities include supporting the preparation and submission of regulatory applications for product registration, renewal, and variations. You will maintain and update internal regulatory databases to ensure accuracy and compliance with Malaysia requirements.

You will liaise with global and regional regulatory teams to obtain required documentation and align strategies. Regular coordination with local health authorities involves compiling submissions and supporting responses to regulatory queries.

This role offers exposure to cross-functional discussions and team meetings, sharing learnings and best practices. You will contribute to regulatory projects while building a foundation for a long-term career in healthcare innovation.

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

Responsibilities

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

Benefits

Inclusive work environment where each person is considered as an individual
Structured learning experience to develop foundational regulatory knowledge
Exposure to regulatory best practices and processes through team meetings and projects
Opportunity to work with cross-functional and global stakeholders across Innovative Medicine and MedTech
Guided by Our Credo, fostering a culture of respect and diversity