Dr. Reddy's Laboratories · 21 hours ago
Regulatory Summer Intern
Princeton, NJ
Internship
Hybrid
InternDr. Reddy's Laboratories is dedicated to making medicines more affordable and discovering innovative treatment options. They are seeking a Regulatory Summer Intern to support ongoing regulatory projects and gain hands-on exposure to various areas within Regulatory Affairs.
BiotechnologyHealth CareMedical
No H1B
U.S. Citizen Only
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
Qualification
Required
Pursuing an undergraduate or graduate degree with a 2027 graduation date from an accredited U.S. based University in any Science discipline
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
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
Preferred
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
Company
Dr. Reddy's Laboratories
Established in 1984, we are a global pharmaceutical company headquartered in Hyderabad, India.
Founded in 1984
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6MKey Investors
Life Insurance CorporationMAPE Advisory Group
2025-06-05Post Ipo Equity
2022-10-03Post Ipo Equity
2001-12-01Post Ipo Equity· $6M
Leadership Team
Erez Israeli
Chief Executive Officer
Lee Banks
VP, Intellectual Property
Recent News
2026-02-02
2026-02-02
Business Standard India
2026-01-23
Company data provided by crunchbase