Associate Regulatory Affairs Manager

GlaxoSmithKline

Petaling Jaya, Malaysia
Product registration and lifecycle management
Artwork creation and compliance
Regulatory governance principles
To hold the Pharmacist Poison License Type A for the company to operate in Malaysia and register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei

Job Summary

  • To hold the Pharmacist Poison License Type A for the company to operate in Malaysia and register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei.
  • To ensure compliance to QMS processes and Artwork Management SOP for Pharma and Vaccines, and undertake timely revision of SOPs for compliance to the current regulatory requirements.
  • To establish and enhance customer oriented and trustful relationships with Health Authorities, Regulatory Bodies, Trade Associations, Regulatory Working Groups.

Matching Summary

To hold the Pharmacist Poison License Type A for the company to operate in Malaysia and register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei.

Skills & Requirements

Must-have

  • Product registration and lifecycle management
  • Artwork creation and compliance
  • Regulatory governance principles
  • QMS processes and SOP compliance
  • External stakeholder relationship management

Nice-to-have

  • Proactive risk mitigation
  • Continuous expertise development
  • Solution-driven attitude
  • Agile working culture

Key Requirements

  • Minimum 5 years regulatory experience
  • Pharmaceutical product artwork management experience
  • Experience in controlled regulatory environment
  • Knowledge of Malaysian Acts & Regulations

Work Rights

Not specified

Tailored Resume

Cover Letter