Regulatory Affairs Intern

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.

• Technical Proficiency: Skilled in MS Word, MS Excel, PowerPoint, PDF, and other relevant applications.
• Time Management: Ability to manage timelines effectively.
• Organization: Well-organized, detail-oriented, and capable of multitasking and managing changing priorities.
• Regulatory Knowledge: Understanding of FDA regulations and FDA/ICH guidelines.
• Communication Skills: Strong oral and written communication skills, independent judgment, problem-solving abilities, and adherence to timelines.
• Educational Background: MS in Regulatory Science or related fields.
• Experience: 0 - 1 year of relevant experience.

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!