Regulatory Affairs Intern
2 weeks ago
Spring 2025 Regulatory Affairs Intern
Company OverviewCipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies.
Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. The successful candidate will be responsible for developing product labeling, including package inserts, container labels, and Medication Guides, for pending and approved ANDAs. Additionally, they will be responsible for archival of electronic submission documents and writing, critical reviewing, compiling, and publishing FDA submissions in eCTD format.
Key Responsibilities- Develop product labeling, including package inserts, container labels, and Medication Guides, for pending and approved ANDAs
- Archival of electronic submission documents
- Writing, critical reviewing, compiling, and publishing FDA submissions in eCTD format
- Reviewing CMC data for adequacy and conformance to regulatory requirements and acceptability of documents for submissions
- Communicating effectively with internal departments, external vendors, and partners to achieve project goals and submission timelines
- BS degree in Pharmacy, Regulatory Affairs, or related field
- 0-1 year of experience in regulatory affairs or related field
- Proficiency in applicable computer and database applications, including MS Word, MS Excel, PowerPoint, and PDF
- Ability to manage timelines, be well-organized, detail-oriented, and have the ability to multi-task and manage changing priorities
- Demonstrable knowledge of FDA regulations and FDA/ICH guidelines
Cipla is a fast-growing pharmaceutical company with a continued focus on expanding our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.
InvaGen Pharmaceuticals, Inc. is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with a focus on a range of therapeutic areas.
Equal Opportunity EmployerCipla is an equal opportunity employer and welcomes people of all abilities. We want to ensure that our hiring and interview process meets the needs of all applicants.
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