J&J Protégé Trainee - Regulatory Affairs

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Career Programs

Job Sub Function:
Non-LDP Intern/Co-Op

Job Category:
Career Program

All Job Posting Locations:
Petaling Jaya, Selangor, Malaysia

Job Description:

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.