Regulatory Summer Intern
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Job Location:
Princeton, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Dr. Reddys is seeking a 2027 graduate for a Regulatory Summer Intern position to support ongoing regulatory projects and datamanagement activities.
This internship will provide handson 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. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :
No
Employment Type :
Intern
Key Skills
- Microsoft Office
- Public Relations
- Google Docs
- Data Collection
- MailChimp
- Microsoft Word
- Dermal Fillers
- Microsoft Powerpoint
- Research Experience
- Microsoft Excel
- Adobe Photoshop
- Writing Skills
About Company
Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Cant Wa ... View more
