Intern – Regional Regulatory Operations – Asia Pacific (AP)

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. We also contribute to the development, implementation, and support of innovative processes and tools that enable efficiency and compliance.

To achieve this mission, RRO-AP embraces innovative business approaches and leverages advanced Regulatory Information Management (RIM) systems to streamline processes. Our team brings diverse expertise and collaborates with global, regional, and local stakeholders to continuously optimize operations through data-driven decision making

RRO-AP encompasses four domains of expertise:

• Regional Planning
• Regional Publishing
• System Process and Regulatory Innovation (SPRI)
• International Labelling Support (ILS)

Position Overview

This internship will primarily support activities within Publishing and SPRI domains. By the end of the program, the intern will:

• Gain a comprehensive understanding and working knowledge of the regulatory dossier publishing process and associated international standards.
• Gain an overall understanding on how RIM tools are used to prepare and deliver regulatory dossiers to country regulatory teams for health authority submission.
• Acquire practical knowledge on how to leverage data for business analyse
• Acquire practical knowledge on simple automation solutions

Key Responsibilities

** Submission Publishing (50%)**

The intern will support RRO-AP Regional Publishers in the following activities based on assignment:

• Support Regional Publishers in preparing and publishing regulatory dossiers for submission to country Health Authority
• Support maintenance of related execution processes and templates in accordance with regional/country requirements for electronic submissions.

__

SPRI (40%)

The intern will support RRO-AP SPRI team in the following SPRI activities based on assignment:

• Support organization and preparation of regional Community of Practice (CoP) and Process & Digital Forum (PDF) sessions to gather feedback, address user queries, and promote adoption of RIM tools and processes.
• Gain knowledge in developing small-scale automation solutions to improve business efficiency.
• Support data collection, analysis, and visualization to generate actionable insights for business process improvements and/or system enhancements
• Provide event planning and logistical support for the 2027 SPRI Synergy event, an annual cross-functional initiative to enhance collaboration and operational excellence lead by AP SPRI team.

__

Others (10%)

• Support team operations by organizing and preparing materials for internal meetings and maintenance of SharePoint site

** Skills:**

• Proficient in Microsoft Office, especially Excel for data processing and analysis.
• Ability to collect, analyze, and present data to support business process improvements and develop simple automation solutions is an advantage
• Strong process orientation with the ability to follow structured workflows and contribute to optimization initiatives by identifying opportunities for improvement.
• A keen learner with strong attention to detail and excellent organizational skills to manage multiple tasks in parallel.
• Effective interpersonal and communication skills to engage with stakeholders and collaborate within the team.

*This role is for the January 2027 intake

Required Skills:

Adverse Event Report, 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 apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/30/2026

***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. **