Associate Project Manager, Regulatory Operations

This is an excellent opportunity for professionals with experience in project coordination, operations, documentation management, regulatory support, or structured workflow environments who are looking to grow their project management capabilities.

Key Responsibilities
Project Planning & Execution

• Execute defined project activities and work packages within established project plans, timelines, and workflows.

• Convert project tasks into actionable plans by coordinating inputs, dependencies, deliverables, timelines, and stakeholder responsibilities.

• Manage priorities, task sequencing, handoffs, and follow-up activities across multiple projects and workstreams.

• Monitor progress, identify risks, delays, missing information, or resource constraints, and escalate issues when required.

Workflow, Systems & Operational Delivery

• Manage project and documentation workflows across platforms such as Windchill, CCMS, TMS, Jira, Confluence, SharePoint, RIMS, and other project management tools.

• Coordinate activities between Regulatory Operations, project teams, reviewers, vendors, and global stakeholders to ensure efficient workflow execution.

• Maintain accurate project data, workflow records, documentation status, and system information.

• Identify and resolve workflow challenges, unclear requirements, delays, and dependencies while ensuring compliance with established processes.

Stakeholder Coordination & Reporting

• Coordinate with Project Managers, functional teams, reviewers, approvers, vendors, and global stakeholders to support project delivery.

• Track actions, approvals, decisions, risks, issues, and key deliverables to ensure project milestones are achieved.

• Prepare project reports, action registers, status updates, handoff documentation, and decision records.

• Provide clear communication regarding priorities, deadlines, deliverables, and project expectations, while escalating unresolved issues when necessary.

Documentation, Compliance & Quality

• Maintain accurate project documentation, trackers, reports, workflow records, and document control processes.

• Ensure project outputs align with regulatory requirements, quality system expectations, submission strategies, and business priorities.

• Review documentation and deliverables for completeness, accuracy, traceability, and readiness before approval, submission, or release.

• Manage impact of regulatory or business changes that may affect project scope, timing, deliverables, or resourcing.

• Support audit readiness by maintaining appropriate records, approvals, decision logs, and supporting documentation.

Continuous Improvement & Capability Development

• Develop knowledge of Regulatory Operations, localisation, content development, project delivery, and operational workflows.

• Identify process inefficiencies, recurring issues, and workflow improvement opportunities, and contribute to process enhancement initiatives.

• Support the development of standard operating procedures, templates, checklists, training materials, and scalable ways of working.

• Participate in process improvement, automation, reporting, and system enhancement projects.

Requirements

• 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.

Preferred 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 is an advantage.

Education

• Bachelor's Degree in Business, Communications, Science, Health Sciences, Engineering, Regulatory Affairs, Project Management, or a related discipline.

• Equivalent education and relevant work experience will also be considered.

Why Join Us?

• Work with regional and global stakeholders on high-impact projects.

• Gain exposure to Regulatory Operations, localisation, technical documentation, and structured project delivery.

• Build your project management expertise within a collaborative and fast-paced environment.

• Contribute to process improvement, operational excellence, and scalable business solutions.

Apply Now!
We welcome applications from candidates who are organised, collaborative, and passionate about driving successful project delivery. If you thrive in a structured environment and enjoy coordinating complex activities across multiple stakeholders, we'd love to hear from you.