HireDiversity

Petaling Jaya, MY

REGULATORY AFFAIRS & QUALITY EXECUTIVE (JANSSEN DIVISION)-7336121016

Description

- Manages the preparation and submission of product registration and follow-up closely on approvals & amendments
- In compliance with the various local regulatory requirements
- Foster and maintain professional and business relationship with the health authorities
- Manage the annual quota demand and permits applications for opiods and Dangerous Drug products
- Manage and coordinate product life cycle management
- Maintain and improve work processes and tracking tools that facilitate performance levels and improve transparency
- Ensure all aspects of product handling and distribution comply with cGMP, regulatory requirements and company standards
- Supervise and coordinate third party activities and ensure the activities of repacking, relabeling, storage and distribution of products are in compliance with company standards
- Accurate maintenance of quality records and in compliance with company standards of practice

Qualifications


- Degree in Pharmacy and registered with the Pharmacy Board of Malaysia
- 1-2 years experience in regulatory affairs is preferred or have a deep interest in pursuing a career in regulatory affairs
- 1-2 years experience in quality assurance is of added value
- Self-driven, pro-active and fast learner
- Able to multitask, react swiftly to urgent issues and work within stipulated deadlines
- Meticulous with an eye for details
- Excellent communication, good interpersonal skills and a team player
- Proficiency in written and spoken Bahasa Malaysia and English

Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:Yes, 10% of the time
Job Function: Regulatory Affairs