Summer Internship: Regulatory Affairs

Regenxbio • Rockville, MD

302d • $20 - $30

About The Position

The Global Regulatory Affairs function at REGENXBIO is comprised of Strategy, Operations, CMC and Medical Writing, and the team has an exciting opportunity for an intellectually-curious, focused intern pursuing careers in Regulatory Affairs. The intern will gain hands on, professional experience in both Regulatory Strategy and Regulatory Operations in support of priority submissions to health authorities worldwide.

Requirements

• Pursuing an undergraduate degree in a relevant engineering / scientific discipline.
• Ability to interpret data, draw conclusions, and recommend next steps.
• Ability to effectively communicate information and results in the appropriate format (i.e., lab notebooks, presentations, reports, etc.).
• Must be able to work collaboratively and effectively as part of a team.
• Proficient in MS Office.
• Good organization skills with the ability to work on several assignments simultaneously.
• Interns must adhere to all federal and/or local regulations, laboratory health and safety procedures, and all company Standard Operating Procedures, policies, and guidelines.

Responsibilities

• Assist local or global regulatory lead(s) to develop submission documents content via coordinating responses to health authority inquiries.
• Authoring administrative submission documents (cover letters, forms & template responses).
• Supporting team reviews and consolidating comments as needed to finalize content.
• Assist Regulatory Operations lead(s) via performing final formatting and content planning in support of electronic submission publishing.
• Secure literature references and copyrights to be included in electronic submissions.
• Support archival and tracking of submission components.
• Conduct regulatory research (via review of applicable regulations, related guidance, and scientific literature) on topics as assigned in support of REGENXBIO programs and initiatives and prepare to present findings and recommendations to a small cross-functional or regulatory sub-team.
• Attend and participate in regulatory RA meetings to gain insight into day-to-day regulatory affairs practices and virtual/hybrid team functioning.

Benefits

• $20 - $30 an hour
• Opportunity for professional development and exposure to challenging projects.

What This Job Offers

• Career Level: Intern
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree