J&J Protégé Trainee - Regulatory Affairs

Johnson & Johnson; Petaling Jaya; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading healthcare company in Malaysia is seeking a highly motivated Regulatory Affairs Protégé Trainee. The role involves supporting regulatory filings, maintaining databases, and liaising with regulatory colleagues. Candidates should have a relevant bachelor's degree and strong communication skills. This position is full-time for 12 months.

Qualifications

• Bachelor's degree required, preferably in a relevant field.
• Proficiency in written and oral English is necessary.
• Ability to effectively communicate complex issues simply.

Responsibilities

• Support regulatory filings for renewal and re-registration.
• Prepare submissions for local health authority.
• Maintain databases of regulatory approvals.
• Liaise with regulatory colleagues for document preparation.
• Contribute to Regulatory Affairs Team meetings.

Skills

Verbal and written communication skills

Ability to interpret complex issues

Team player

Education

Bachelor's degree in Pharmacy, Engineering, Life Science or related discipline

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.