Regulatory Affairs Intern

Job Title: Regulatory Affairs Intern

Location: Research Triangle Park, NC- 27709

Duration: 3 Month Contract

Pay Rate: $20/hr – $21/hour

Estimated Hours per Week: 20

Position Summary

• The Regulatory Affairs Internship provides graduate students with the opportunity to apply academic training to real world challenges in the rapidly evolving field of cell and gene therapy.
• Working within a cross functional regulatory team, the intern supports activities that ensure compliance with global health authority requirements while contributing to the advancement of

transformative therapies for patients.

Job Responsibilities

• Support the preparation, review, and organization of regulatory submissions, including original INDs/CTAs and amendments, health authority briefing packages and information requests/responses, and CMC documentation.
• Apply regulatory science principles learned in coursework to evaluate guidance documents, regulatory precedents, and emerging policies relevant to advanced therapy medicinal products (ATMPs).
• Assist in developing regulatory strategies for early-stage and clinical-stage cell and gene therapy programs.
• Participate in cross-functional meetings with Quality, CMC, Clinical, Translational Medicine, and Program Management teams to understand how regulatory considerations shape product development.
• Identify challenges in regulatory processes or documentation workflows and propose practical, well-reasoned solutions.
• Contribute to internal regulatory intelligence efforts by summarizing new FDA, EMA, and ICH updates and assessing their impact on ongoing programs.
• Observe and document the organization’s culture, structure, and decision-making processes, including interactions with internal stakeholders and external partners.
• Engage with regulatory professionals and subject matter experts to gain mentorship, career guidance, and insight into industry best practices.
• Participate in networking opportunities, team events, and professional development sessions to build connections across the organization.
• Support with Regulatory Submission and other Regulatory Operations related activities

Minimum Requirements

• Currently enrolled in a Masters of Pharmaceutical Sciences Regulatory Sciences Program with at least one semester of coursework completed · Strong understanding of drug development processes and regulatory frameworks · Basic understanding of Health and Human Services (HHS), and Food and Drug Administration (FDA) · Excellent English written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) · Strong attention to detail and organizational skills · Ability to work both independently and collaboratively in a team environment · Demonstrated interest in cell and gene therapy or biologics regulation

Preferred Education, Experience and Skills

• Previous internship or work experience in pharmaceutical, biotech, or regulatory environments Knowledge of FDA and ICH guidelines relevant to biologics and advanced therapies
• Understanding of GMP, GCP, GLP, and quality systems
• Experience with regulatory information management systems