Regulatory Affairs Intern

Regulatory Affairs Internship

Estimated Time Commitment: 15–20 hours per week, with flexibility based on team needs. The internship is expected to run through the full June–August timeframe.

Regulatory Policy & Intelligence

Objective: To support the Regulatory Strategy team in monitoring, analyzing, and communicating key U.S. and global regulatory developments that may impact the company’s pipeline, strategic initiatives, assist with regulatory intelligence, research, and support operational activities for ongoing regulatory projects.

The intern would support four key areas: regulatory monitoring and intelligence, regulatory insight preparation, and general project support. Four core responsibilities include:

• Conduct research on emerging regulatory requirements by reviewing global health authority guidance and policy updates.
• Analyze and synthesize regulatory trends to support internal planning and strategic decision-making.
• Prepare clear summaries and reports to communicate key regulatory insights to stakeholders.
• Support regulatory projects through document organization, information tracking, and operational tasks.

Detailed Responsibilities: additional context for the above, the intern may be asked to:

1. Regulatory Monitoring & Intelligence
   1. Conduct in-depth research on emerging U.S. and global regulatory requirements by reviewing health authority guidance, policy updates, and public communications to identify relevance to the company’s development programs.
   2. Analyze and synthesize regulatory trends across agencies, evaluating potential implications for pipeline assets and summarizing insights to support internal planning and strategic decision-making.
2. Regulatory Insight Preparation
   1. Prepare comprehensive summaries, reports, and briefing materials that clearly communicate key regulatory findings, risks, and considerations to the Regulatory Strategy team and cross-functional stakeholders.
3. Project & Team Support
   1. Participate in bi-weekly team meetings and present updates on assigned projects.
   2. Provide operational and project support by organizing regulatory documents, maintaining trackers, monitoring project milestones, and assisting with day-to-day activities to ensure efficient execution of regulatory initiatives.
   3. Participate in cross-functional clinical team meetings to develop an understanding of diverse functional roles and their impact on clinical programs.

Regulatory Operations/Regulatory Project Management

Support with operations activities (planning, submissions, timelines, lifecycle, archiving)

Support development of IND/NDA processes (SOPs and Work Aids)

Regulatory Affairs Rotations

Rotation in all regulatory sub teams (Strategy, Chemistry Manufacturing and Control, Project Management, Regulatory Writing, Data Disclosure and Transparency)