Regulatory Summer Intern – Regulatory Affairs (Generic Pharmaceuticals)
Location: Princeton, New Jersey, USA
Business Unit: North America Group (NAG)
Department: Regulatory Affairs – General
Internship Duration: June 1, 2026 – August 14, 2026
Work Model: Hybrid (4 days onsite, 1 day remote per week)
Experience Required: Current Undergraduate or Graduate Student (Expected Graduation Year: 2027)
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories is a global pharmaceutical company committed to accelerating access to affordable and innovative medicines. Operating across multiple international markets, the organization plays a significant role in generic drug development, regulatory compliance, and lifecycle management.
Driven by its purpose, “Good Health Can’t Wait,” Dr. Reddy’s focuses on scientific excellence, regulatory integrity, and operational efficiency across its North America and global businesses. The company fosters an inclusive and performance-driven work environment.
Internship Overview
Dr. Reddy’s is seeking a Regulatory Summer Intern (Class of 2027) to support ongoing regulatory affairs projects within the North America Group (NAG). This internship provides hands-on experience in generic drug regulatory submissions, data management, eCTD compliance, and FDA documentation processes.
The role is designed to offer practical exposure to the full lifecycle of ANDA and NDA submissions, regulatory documentation management, and compliance validation activities within a U.S. pharmaceutical regulatory environment.
Key Responsibilities
Verify establishment information for Drug Substance (DS) and Drug Product (DP) manufacturing sites included in ANDA and NDA applications as part of structured data validation initiatives.
Create and maintain the Approved Products Master List, including updates to DUNS (Data Universal Numbering System) and FEI (FDA Establishment Identifier) numbers.
Support archival, maintenance, and organization of regulatory submissions and FDA correspondences, ensuring timely routing of agency communications to relevant stakeholders.
Conduct compliance reviews of published eCTD (electronic Common Technical Document) submissions to ensure alignment with current FDA regulatory requirements.
Assist in reviewing change controls and supporting regulatory impact assessments linked to departmental initiatives.
Perform systematic reviews of product folders to verify that FDA-submitted sequences are complete and up to date.
Develop and maintain Drug Product History Files as part of documentation standardization projects.
Contribute to cross-functional regulatory projects based on business priorities, gaining exposure to multiple verticals within Regulatory Affairs.
Educational Qualifications
Currently pursuing an undergraduate or graduate degree in a Science discipline from an accredited U.S.-based university
Expected graduation year: 2027
Preference for candidates pursuing studies in Regulatory Affairs, Pharmaceutical Sciences, Life Sciences, or related disciplines
Experience Requirements
No prior full-time experience required
Academic exposure to pharmaceutical regulatory affairs, FDA guidelines, or drug development processes is advantageous
Required Skills and Competencies
Technical Skills
Basic understanding of FDA regulatory frameworks, ANDA/NDA processes, and eCTD submission formats (preferred)
Proficiency in Microsoft Excel, PowerPoint, and standard office applications
Strong data organization and documentation skills
Ability to interpret and validate regulatory data sets
Behavioral Competencies
Strong written and verbal communication skills
Attention to detail and compliance-oriented mindset
Ability to quickly learn regulatory systems and internal processes
Collaborative team player with strong organizational skills
Eligibility Requirements
Must be a U.S. citizen, lawful permanent resident, or otherwise authorized to work in the United States without current or future visa sponsorship
Professional Development Opportunity
This Regulatory Affairs internship provides structured exposure to:
Generic pharmaceutical regulatory submissions (ANDA/NDA)
FDA compliance processes and data validation
Regulatory documentation management and archival systems
Cross-functional collaboration within a global pharmaceutical organization
The program is ideal for students seeking a career path in Regulatory Affairs, Pharmaceutical Regulatory Strategy, Drug Development Compliance, or Global Regulatory Operations.
Equal Opportunity Employer
Dr. Reddy’s Laboratories is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to legally protected characteristics.
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