Regulatory Summer Intern

Dr Reddy's Laboratories Limited • Princeton, NJ

1d • Hybrid

About The Position

Dr. Reddy’s is seeking a 2027 graduate for a Regulatory Summer Intern position to support ongoing regulatory projects and data‑management activities.
This internship will provide hands‑on exposure to multiple areas within Regulatory Affairs and offer insight into the full life cycle of generic drug regulatory filings.

Requirements

• Pursuing an undergraduate or graduate degree with a 2027 graduation date from an accredited U.S. based University in any Science discipline.
• Good oral and written communication skills
• Experience with Excel/PowerPoint skills
• Basic computer skills
• Ability to quickly grasp and learn about the work assigned by team members
• Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.
• This role follows a hybrid work model, requiring the intern to be onsite in the Princeton office four (4) days per week, with one (1) day of remote work permitted. The internship program will run from June 1, 2026 to August 14, 2026.

Nice To Haves

• Preference would be given to candidates who are currently pursuing programs focusing on Regulatory affairs or any other relevant areas in pharmaceutical field.
• Basic understanding of FDA regulatory requirements is a Plus
• Basic understanding of various regulatory filing types and submission formats

Responsibilities

• Verify establishment information (Drug Substance and Drug Product manufacturing site details) for Dr. Reddy’s ANDA and NDA applications as part of an ongoing data validation project.
• Create and maintain the Approved Products Master List, including project-based updates to applicant holder DUNS (Data Universal Numbering System) and FEI (FDA Establishment Identifier) numbers.
• Support Regulatory Affairs personnel with a project focused on the maintenance, archival, and organization of regulatory submissions and agency correspondences; ensure FDA email notifications are routed timely to relevant stakeholders.
• Assist with compliance checks of published eCTD (electronic Common Technical Document) submissions, performing project-driven reviews to confirm alignment with current regulatory requirements.
• Participate in the review and approval of change controls as needed, supporting regulatory evaluations tied to departmental initiatives.
• Conduct a systematic review of product folders to confirm all FDA-submitted sequences are accurately copied and current.
• Create and maintain Drug Product History Files (25+), contributing to a broader documentation standardization project.
• Opportunity: Based on current business needs, there is potential for the intern to support additional projects across other verticals within Regulatory, providing broader exposure to cross-functional regulatory and operational activities.

What This Job Offers

• Career Level: Intern