What are the responsibilities and job description for the Regulatory Affairs Intern position at Cipla USA?
Compensation : $20 / hr - $25 / hr
Location : on-site 5 days / week in East Islip, NY
Duration : 10 weeks (Feb / March start)
Are you ready to kickstart your career in Regulatory Affairs? Join us at Cipla for an engaging and dynamic internship experience where you'll make a real impact!
Responsibilities / Accountabilities :
- Develop Product Labeling : Create package inserts, container labels, and Medication Guides for both pending and approved ANDAs.
- Electronic Submissions : Ensure all electronic submission documents are accurately filed in product-specific files.
- FDA Submissions : Write, critically review, compile, and publish FDA submissions in eCTD format.
- Review CMC Data : Ensure data meets regulatory requirements and is suitable for submissions.
- Effective Communication : Collaborate with internal departments, external vendors, and partners to achieve swift project completion and meet submission timelines.
- Direct Reporting : Work closely with our Head of Regulatory Affairs.
- Professional Development : Participate in a volunteer event and a professional development seminar. Present a 10-15 minute summary of your internship experience at the end of the program.
Skills / Competencies :
Join us at Cipla and gain hands-on experience in the exciting field of Regulatory Affairs. Apply now and be part of a team that's making a difference in healthcare!
We can't wait to see what you'll bring to our team!
Salary : $20 - $25