Global Regulatory Affairs Intern
This summer internship will offer college and university students an outstanding opportunity to gain hands on experience within the pharmaceutical industry. This program allows students to work closely with business leaders while acquiring industry insight. Interns will be tasked with both individual and group projects. The Sunovion Internship Program will offer additional workshops and seminars for your career and professional development. We are seeking dedicated individuals within multiple areas across the organization.
Specific Internship Description:
This internship will be crafted with the business need and candidate interest in mind but could include any of the following:
- Understand all aspects of Global Regulatory Affairs
- Help plan, process, and review Regulatory submissions prior to dispatch to the health authority
- Learn the process used to write and publish clinical documents
- Be exposed to the strategies used when interacting with the health authorities for clinical trial applications (INDs, CTAs) and marketing approvals (NDAs, MAAs).
- Compile, publish, and validate submissions in accordance with regulatory agency specifications and standards
- Work with Global Regulatory Leads in the assessment of clinical trial and marketing approval applications (INDs, NDAs, CTAs, MAAs, etc.)
- Write and edit medical writing deliverables across multiple phases of clinical research
Learning Goals:
- The intern would be provided with exposure to three groups within Sunovion's Regulatory department: Regulatory Affairs, Regulatory Operations and Medical Writing.
- Gain insight into the Regulatory side of the pharmaceutical industry
- Enhance communication skills by working with vendors and cross-functional team members
- Develop familiarity with the electronic common technical document (eCTD)
- Develop project management skills by planning submissions to health authorities
- Understand the basic fundamentals and concepts of the Regulatory Operations publishing process
- Publish and QC clinical documentation used in Regulatory Submissions and applications
- Gain expertise in the processing of promotional materials to the office of Prescription Drug Promotion (OPDP)
- Learn about the software and systems used in processing Regulatory submissions (e.g. Veeva, Adobe)
Minimum Requirements:
- Enrolled in PharmD degree program
- Must have completed their second year (P2) of study by Summer 2023
- Authorization to work in the U.S. without requiring sponsorship
- Experience using Microsoft Office (Excel, PowerPoint, Word.)
- Strong communication skills and passion for continued development
- Covid-19 Vaccinations are required
Program Details:
- Position will begin on Monday June 5, 2023
- Position is located remotely in the US
- Position is full-time Monday through Friday – up to 40 hours per week
- Candidates should be available to commit to 10 weeks
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious Central Nervous System (CNS) conditions. Sunovion’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with Central Nervous System (CNS) conditions.