This MNC company in Healthcare is looking for a Regulatory Affairs Senior Analyst (12-month contract) to join their team.
- Support regional regulatory activities across multiple markets, including preparation, maintenance, and updates of product registrations throughout the regulatory life cycle.
- Assist in quality and compliance operations, including documentation control, procedural updates, issue remediation, and support for corrective and preventive actions.
- Review commercial and technical materials to ensure alignment with applicable regulatory requirements and internal governance standards.
- Perform post-market compliance activities such as safety reporting assessments and coordination of related follow-up actions, while maintaining readiness for regulatory review.
Salary up to MYR 7,000
Requirements
- 13 years of hands-on experience supporting regulatory submissions and maintenance activities within a regulated healthcare environment; exposure to multiple regional authorities is an advantage.
- Working knowledge of local regulatory frameworks, including product registration, labeling requirements, and change control processes.
- Ability to engage effectively with cross-functional stakeholders and operational teams in a professional and collaborative manner.
- Strong organizational and project coordination skills, with the flexibility to manage competing priorities, meet timelines, and perform well in a fast-paced setting.
