Regulatory Summer Intern at Dr Reddy's Laboratories Limited

Princeton, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

0.0

Posted On

04 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oral Communication, Written Communication, Excel, PowerPoint, Basic Computer Skills, Quick Grasping, Regulatory Affairs, Data Management, Data Validation, Archival, Organization, Compliance Checks, Change Controls, Documentation Standardization

Industry

Pharmaceutical Manufacturing

Description

Company Description At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. Diversity, Equity & Inclusion At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Job Description 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. Job Duties and 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. Qualifications Pursuing an undergraduate or graduate degree with a 2027 graduation date from an accredited U.S. based University in any Science discipline. Preference would be given to candidates who are currently pursuing programs focusing on Regulatory affairs or any other relevant areas in pharmaceutical field. Skills/Attributes: 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 Basic understanding of FDA regulatory requirements is a Plus Basic understanding of various regulatory filing types and submission formats Additional Information 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. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at https://careers.drreddys.com/#!/ Job Family: Regulatory Affairs Sub Job Family: Regulatory Affairs General Preferred type of working: Hybrid Years of Experience: 0 - 1 Business unit: NAG

Responsibilities

The intern will support ongoing regulatory projects by verifying establishment information for drug applications and maintaining master lists, including updating DUNS and FEI numbers. Responsibilities also include assisting personnel with the maintenance and organization of regulatory submissions and agency correspondences.