J&J Protégé Trainee - Regulatory Affairs

We are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Protégé Trainee for 12 months. The successful candidate will be responsible for supporting regulatory filings for renewal/re-registration, submissions related to changes of the assigned product portfolios or projects & document management.

This position reports to the Manager, Regulatory Affairs.

• The Regulatory Affairs Protégé Trainee will be a member of the local Regulatory Affairs department within Johnson & Johnson Sdn Bhd, Malaysia, with responsibility for regulatory aspects of the assigned product portfolios or Projects;
• Preparation of submissions to the local health authority for renewal/re-registration and changes to existing products in line with Marketing launch plans;
• Maintain internal and source company databases of regulatory approvals;
• Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Malaysia and request the documentation required for registration submissions;
• Work with the local health authority by compiling and submitting required documents and providing responses to questions via return applications;
• Contribute to Regulatory Affairs Team meetings to learn from colleagues, share experiences and best practice;
• Any other activities as per assigned by Regulatory Affairs Manager.

Minimum Qualification

• A bachelor's degree, preferably in Pharmacy, Engineering, Life Science or any related discipline.

Other Requirements

• Excellent verbal and written communication skills - proficiency in written and oral English is required;
• Ability to interpret complex issues and present them in simple terms to facilitate understanding by others;
• Proactive team player, able to take charge and follow-through.