AbbVie Inc., in collaboration with the University of Southern California School of Pharmacy, offers you a distinctive pharmaceutical industry fellowship advantage – a global, diverse, research-based organization that will develop your skills, expand your potential, and optimize your career.
This year, fellowships are offered in the following areas:
Regulatory Affairs – Strategy
In the past, Global Regulatory Affairs – Strategy fellows have had the opportunity to:
Lead and contribute to projects within GRA including assembly and management of regulatory documents for various FDA and other Health Authority (HA) submissions that meet regulatory standards?
Obtain experience in preparing for FDA or other HA meetings including development of meetings requests, briefing packages, and coordinating FDA rehearsal meetings ?
Cross functional interactions with key development stakeholders such as Clinical Development, Project Management, Manufacturing, Research and Development, RA-Chemistry, Manufacturing and Control (CMC), Drug Safety, Toxicology, Clinical Pharmacokinetics, Labeling, Quality Assurance, Publishing, and Marketing to discuss issues specific to drug development and enhance the practical application of the information acquired?
Obtain insight on developing regulatory strategies for drug, medical device and combination products development, clinical study planning, and project implementation with Asset Strategy Team and RA leadership?
Become knowledgeable on US regulations, FDA guidance documents and ICH guidelines that are relevant to assigned projects ?
Complete assessments of regulatory landscape to generate regulatory intelligence relevant to assigned therapeutic areas
AbbVie’s mission is to create an innovation-driven, patient-focused specialty biopharmaceutical company capable of achieving sustainable top-tier performance through outstanding execution and a consistent stream of innovative new medicines which have a remarkable impact on people’s lives. Today, our medicines help 52 million people living in more than 175 countries, and we are making significant advancements with a robust pipeline of potential new medicines.
Fellows in our program have the benefit to further enhance their experience through the academic component at the University of Southern California School of Pharmacy, one of the nation's leading schools of pharmacy. Fellows are given the opportunity to take graduate courses in the Regulatory Science program, lecture in the School of Pharmacy, and share in the strong network of USC alumni.
Interviews at the ASHP Midyear meeting are limited and are granted on a competitive basis. Please apply for an interview by submitting an application through the PPS portal.
Please submit a Curriculum Vitae and a Letter of Intent through the Personal Placement Service (PPS) to request for an interview. Interviews at the ASHP Midyear meeting are limited and are granted on a competitive basis.
Please follow the document conventions listed below.
Document type: PDF
Document name: Last Name_First Name_CV.pdf
Letter of intent
Document type: PDF
Document name: Last Name_First Name_Letter.pdf
The letter of intent should address your career goals in industry and why you are interested in the USC-AbbVie Regulatory Affairs Fellowship.
Applicants must have a Pharm.D., Ph.D., or DRSc. at the time of matriculation into the fellowship program and a minimum doctoral program GPA of 3.0. Applicants will receive a confirmation email after completion of the application and a follow up email will be sent out with further instructions for the interview process.
Thank you for your interest in the USC-AbbVie Global Regulatory Affairs Fellowship.
The University of Southern California is one of the world’s leading private research universities. An anchor institution in Los Angeles, a global center for arts, technology and international trade, USC enrolls more international students than any other U.S. university and offers extensive opportunities for internships and study abroad. With a strong tradition of integrating liberal and professional education, USC fosters a vibrant culture of public service and encourages students to cross academic as well as geographic boundaries in their pursuit of knowledge.