Intern- Regional Regulatory Operations – Asia Pacific

<p style="text-align:left">Job Description</p><p style="text-align:inherit"></p><p><span style="color:#000000"><b><span style="font-size:14px">Position Overview & Responsibilities</span></b></span></p><p><span style="color:#000000"><b>Regional Regulatory Operations – Asia Pacific (RRO-AP)</b></span></p><p><span style="color:#000000">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.</span></p><p><span style="color:#000000"> </span></p><p><span style="color:#000000">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</span></p><p><span style="color:#000000"> </span></p><p><span style="color:#000000">RRO-AP encompasses four domains of expertise:</span></p><ul><li><p><span style="color:#000000">Regional Planning</span></p></li><li><p><span style="color:#000000">Regional Publishing</span></p></li><li><p><span style="color:#000000">System Process and Regulatory Innovation (SPRI)</span></p></li><li><p><span style="color:#000000">International Labelling Support (ILS)</span></p></li></ul><p><span style="color:#000000"><b> </b></span></p><p><span style="color:#000000"><b>Position Overview</b></span></p><p><span style="color:#000000">This internship will primarily support activities within Publishing and SPRI domains. By the end of the program, the intern will:</span></p><ul><li><p><span style="color:#000000">Gain a comprehensive understanding and working knowledge of the regulatory dossier publishing process and associated international standards.</span></p></li><li><p><span style="color:#000000">Gain an overall understanding on how RIM tools are used to prepare and deliver regulatory dossiers to country regulatory teams for health authority submission.</span></p></li><li><p><span style="color:#000000">Acquire hands-on experience with selected RIM tools and their role in enabling efficient regulatory operations.</span></p></li><li><p><span style="color:#000000">Acquire practical knowledge on how to leverage for business analyses</span></p></li><li><p><span style="color:#000000"><span style="font-size:14px">Acquire practical knowledge on simple automation solutions</span></span></p></li></ul><p></p><p><span style="color:#000000"><b><span style="font-size:14px">Key Responsibilities:</span></b></span></p><p><span style="color:#000000"><b><u>Submission Publishing (30%)</u></b></span></p><p><span style="color:#000000">The intern will support RRO-AP Regional Publishers in the following activities based on assignment:</span></p><ul><li><p><span style="color:#000000">Support Regional Publishers in preparing and publishing regulatory dossiers for submission to country Health Authority</span></p></li><li><p><span style="color:#000000">Support maintenance of related execution processes and templates in accordance with regional/country requirements for electronic submissions.</span></p></li></ul><p></p><p><span style="color:#000000"><b><u>SPRI (60%)</u></b></span></p><p><span style="color:#000000">The intern will support RRO-AP SPRI team in the following SPRI activities <span style="font-size:14px">b</span>ased on assignment:</span></p><ul><li><p><span style="color:#000000">Help organize 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.</span></p></li><li><p><span style="color:#000000">Gain hands-on experience in developing small-scale automation solutions to improve business efficiency.</span></p></li><li><p><span style="color:#000000">Support data collection, analysis, and visualization to generate actionable insights for business process improvements and/or system enhancements</span></p></li><li><p><span style="color:#000000">Support document template management, access requests, and security controls in the company’s Content Management System and Labelling System.</span></p></li><li><p><span style="color:#000000">Provide logistical support for the 2026 SPRI Synergy event, an annual cross-functional initiative to enhance collaboration and operational excellence lead by AP SPRI team.</span></p></li></ul><p></p><p><span style="color:#000000"><b><u>Others (10%)</u></b></span></p><p><span style="color:#000000"><span style="font-size:14px">Support team operations by organizing internal meetings, maintaining the SharePoint site, and contributing improvement ideas to enhance process efficiency.</span></span></p><p></p><p><span style="color:#000000"><b><u><span style="font-size:14px">Skills:</span></u></b></span></p><ul><li><p>Proficient in Microsoft Office, especially Excel for data processing and analysis.</p></li><li><p>Ability to collect, analyze, and present data to support business process improvements and develop simple automation solutions is an advantage</p></li><li><p>Strong process orientation with the ability to follow structured workflows and contribute to optimization initiatives by identifying opportunities for improvement.</p></li><li><p>A keen learner with strong attention to detail and excellent organizational skills to manage multiple tasks in parallel.</p></li><li><p>Effective interpersonal and communication skills to engage with stakeholders and collaborate within the team.</p></li></ul><p></p><p><b>Required Skills: </b></p>Accountability, Adverse Event Report, Audits Compliance, Business Strategies, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Mentorship, Policy Implementation, Records Retention Management, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Strategy Development<p></p><p><b>Preferred Skills: </b></p><p style="text-align:inherit"></p><p style="text-align:left">Current Employees apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left">Current Contingent Workers apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Search Firm Representatives Please Read Carefully </b><br />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. </p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Intern/Co-op (Fixed Term)<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements:</span></b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p>Hybrid<p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Posting End Date:</b></p>01/30/2026<p style="text-align:left"><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p><br><p><b>Requisition ID:</b>R372877</p>