SUMMARY OF POSITION
e5 Pharma, LLC is seeking a motivated and talented individual to join our summer internship program which offers meaningful project experiences that gives interns the opportunity to gain valuable pharmaceutical industry experience as they complete their academic journey.
The Regulatory Affairs intern will support regulatory projects consistent with company goals by working closely with the Director, Regulatory Affairs and cross-functional team members, including Business Development, Quality Assurance, and Project Management. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment.
ROLES AND RESPONSIBILITES
- Assist in the preparation of regulatory documentation for submission to the FDA
- Coordinate, collect, store GMP documentation needed to support regulatory submissions
- Provide support within the organization as needed
REQUIRED QUALIFICATIONS
- Must be enrolled in a full time undergraduate or graduate degree program at an accredited 4-year institution pursing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) and entering junior year or above
- Demonstrated ability to balance academic and extracurricular commitments (i.e. work experience, clubs, volunteer activities, teams, etc.)
- Organized, responsible, and detail-oriented
- Proficient in Microsoft Word, Excel, and PowerPoint
- Must be able to work well within a team and independently at times with limited guidance
PREFERRED QUALIFICATIONS
- Ability to thrive in a fast-paced, dynamic, and deadline-driven environment
- Self-motivated with the ability to prioritize/execute multiple concurrent tasks
- Strong, professional communication skills
- Skilled in presentation development and public speaking
- General curiosity and a desire to learn new material