Demo

Regulatory Affairs Intern

Cipla USA
Central, NY Intern
POSTED ON 2/23/2025
AVAILABLE BEFORE 5/19/2025

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 :

  • 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!

    Salary : $20 - $25

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