Job Description
Regional Regulatory Operations – Asia Pacific (RRO-AP)
RRO-AP’s mission is to deliver high‑quality, timely regulatory submissions for our products by providing regional operational expertise and supporting the development of innovative processes and tools for efficiency and compliance.
Position Overview
This internship will primarily support activities within the Publishing and SPRI domains. By the end of the program, the intern will:
- Gain a comprehensive understanding of the regulatory dossier publishing process and associated international standards.
- Understand how RIM tools are used to prepare and deliver regulatory dossiers to country regulatory teams for health authority submission.
- Acquire practical knowledge on leveraging data for business analysis.
- Acquire practical knowledge on simple automation solutions.
Key Responsibilities
Submission Publishing (50%)
The intern will support RRO‑AP Regional Publishers in the following activities:
- Prepare and publish regulatory dossiers for submission to country Health Authorities.
- Maintain related execution processes and templates in accordance with regional/country requirements for electronic submissions.
SPRI (40%)
The intern will support the SPRI team in the following activities:
- Organize and prepare regional Community of Practice (CoP) and Process & Digital Forum (PDF) sessions.
- Develop small‑scale automation solutions to improve business efficiency.
- Collect, analyse, and visualise data to generate actionable insights for process improvements and system enhancements.
- Provide event planning and logistical support for the 2027 SPRI Synergy event.
Other tasks (10%)
- Support team operations by organising and preparing materials for internal meetings and maintaining the SharePoint site.
Skills & Qualifications
- Proficient in Microsoft Office, especially Excel for data processing and analysis.
- Ability to collect, analyse, and present data to support business process improvements and develop simple automation solutions.
- Strong process orientation and ability to follow structured workflows.
- Keen learner with strong attention to detail and excellent organisational skills.
- Effective interpersonal and communication skills.
- Internship start: January 2027.
Required Skills
- Adverse Event Reporting
- Audits Compliance
- Data Quality Assurance
- Document Control Systems
- Electronic Common Technical Document (eCTD)
- Employee Training Programs
- Policy Implementation
- Records Retention Management
- Regulatory Applications
- Regulatory Communications
- Regulatory Compliance
- Regulatory Compliance Audits
- Regulatory Strategy Development
Preferred Skills
Current Employees and Current Contingent Workers may apply.
Other Information
- Employee Status: Intern/Co‑op (Fixed Term)
- Relocation: None
- VISA Sponsorship: None
- Travel Requirements: None
- Flexible Work Arrangements: Hybrid
- Shift: Not specified
- Valid Driving Licence: Not required
- Hazardous Material(s): None
- Job Posting End Date: 09/30/2026 (effective until 11:59:59 PM on the day before the listed end date)
Requisition ID: R401516