Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.Â
- Vacancy details:
- Department: Intern – Regulatory Affairs
- Qualification: BS degree Pharmacy, Regulatory affairs or related field
- Experience: 0-1 years
Job Description –: Greeting from Syngene International Limited!!!!
Important Details :
- Location: Central Islip-Â United States
- Post of date:08/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Responsibilities/ Accountabilities
Responsible for development of product labeling, including package inserts, container labels, Medication Guides, for the pending and approved ANDAs
Responsible for archival of the electronic submission documents in the product specific files.
Write, critical review, compile, and publish FDA submissions as needed in eCTD format.
Responsible for reviewing CMC data for adequacy and conformance to regulatory requirements and acceptability of documents for submissions.
Communicate effectively with other internal departments, external vendors and partners with the goal of achieving the shortest possible time from project inception to product launch and assure submission timelines are met.Â
Reporting directly to our Head of Regulatory Affairs.
You will be required to attend a volunteer event and professional development seminar as part of your internship experience. You will also be assigned a ten (10) to fifteen (15) minute presentation at the end of the internship to express what you learned throughout your time working at Cipla and what you are taking away from the experience
Skills/ Competencie
Must be proficient in applicable computer and database applications including MS Word, MS Excel, PowerPoint, PDF etc.
Ability to manage the timelines.
Must be well organized, detail orientated, have the ability to multi-task and manage changing priorities.
Demonstrable applicable knowledge n FDA regulations and FDA/ICH guidelines are also required.Â
Demonstrable acceptable skills in oral and written communications, independent judgement, problem solving and effective managing and adhering to timelines.Â
MS In Regulatory Science or related fields.Â
