Regulatory Planning & Publishing Intern: eCTD & Compliance

Monmouth University; Rahway (NJ); Hybrid; USD 25,000 - 30,000; Full time

Job summary

Merck is offering a Regulatory Planning and Publishing Intern role in Rahway, NJ, designed for undergraduates receiving Pell grants. You will gain hands-on experience preparing drug applications for FDA/EMA, supporting cross-functional teams with timelines, tracking submissions, and formatting documents into eCTD.

This internship builds foundational skills bridging science and regulatory compliance. Candidates should be quick learners, able to multitask in a fast-paced environment, and

Qualifications

• Undergraduate student with GPA 3.0+ preferred.
• Ability to multitask and adapt in a fast-paced environment.
• Proficiency with MS Office 365 tools (SharePoint, Teams, Outlook, Word, PowerPoint & Excel).
• Demonstrated self-advocacy and resourcefulness.

Responsibilities

• Assist in preparing regulatory submissions for global health authorities (FDA, EMA).
• Support cross-functional teams with project timelines and data submissions.
• Format technical documents into the eCTD format.
• Learn regulatory planning and publishing processes while contributing to life-cycle activities.

Skills

Quick learner

Multitasking

Self-advocacy

Data analysis

Education

Undergraduate student

Tools

SharePoint

Teams

Outlook

Word

PowerPoint

Excel

Job description

Merck is offering a Regulatory Planning and Publishing Intern role in Rahway, NJ, designed for undergraduates receiving Pell grants. You will gain hands-on experience preparing drug applications for FDA/EMA, supporting cross-functional teams with timelines, tracking submissions, and formatting documents into eCTD.

This internship builds foundational skills bridging science and regulatory compliance. Candidates should be quick learners, able to multitask in a fast-paced environment, and