Associate Project Manager, Regulatory Operations
On-siteKuala Lumpur, Kuala Lumpur, Malaysia
Job Summary
Execute defined project activities and work packages within established plans, timelines, and workflows for Regulatory, Content Development, and Localisation initiatives. Coordinate inputs, dependencies, and stakeholder responsibilities while monitoring progress, identifying risks, and escalating issues as required. Manage project documentation, system records, and workflow execution across platforms like Windchill, Jira, and SharePoint to ensure compliance and data accuracy. Track actions, approvals, and key deliverables to support project milestones and prepare status reports for global stakeholders. Maintain accurate documentation and support audit readiness by managing decision logs and change control processes. Identify process inefficiencies and contribute to continuous improvement initiatives, including standard operating procedures and automation projects.
Required Qualifications
- 3–5 years of experience in project coordination, project management support, operational workflows, documentation delivery, localisation, change control, submissions support, or similar structured business environments
- Proven ability to coordinate projects, workstreams, workflows, or operational delivery activities within established governance frameworks
- Strong organisational, planning, stakeholder management, and follow-up skills
- Excellent attention to detail with the ability to manage multiple priorities and deadlines simultaneously
- Experience using project management, workflow, document management, and collaboration systems
- Ability to work effectively with cross-functional and global teams across different time zones
- Comfortable managing ambiguity while maintaining structure, alignment, and delivery focus
- Strong written and verbal communication skills in English
- Bachelor's Degree in Business, Communications, Science, Health Sciences, Engineering, Regulatory Affairs, Project Management, or a related discipline
Desired Qualifications
- Experience in regulatory submissions, technical documentation, labelling, localisation, quality systems, or medical device environments
- Familiarity with Windchill, CCMS, TMS, RIMS, Jira, Confluence, SharePoint, project tracking systems, or similar platforms
- Exposure to regulated industries, product development, quality systems, operational reporting, or controlled documentation environments
- Experience supporting global teams, Centres of Excellence (CoE), shared services, or cross-functional project teams
- Project management, operations, documentation control, or change management training/certification
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.