GlaxoSmithKline Global Regulatory Affairs Fellowship
This global regulatory affairs fellowship is sponsored in collaboration with GlaxoSmithKline
- Length: Two years
- Recruitment Brochure
The Global Regulatory Affairs fellowship at GlaxoSmithKline provides practical training and experience in key regulatory functions to help fellows gain expertise in the regulatory requirements and strategy pertinent to drug development.
Fellows will develop an in-depth understanding of regulatory affairs and the drug development process from pre-clinical to post-marketing stages. Fellows will establish a strong foundation of expertise and knowledge to lead a successful career within the pharmaceutical industry, Food and Drug Administration (FDA), or Contract Research Organizations (CROs).
The fellowship sponsors intend for fellows to be based out of the GSK R&D Site in Upper Providence, PA or Waltham, MA throughout the 2-year duration of the fellowship program.
- Develop regulatory strategy by using and interpreting regulations and guidelines
- Provide support to the life-cycle management activities pre- and post-approval, for drug and biologic products and gain an understanding of the principles of agency review processes
- Gain an understanding of early and late phase clinical development and gain expertise in the requirements of regulatory submissions
- Understand the various facets of global regulatory affairs, including labeling, advertising and promotion, regulatory intelligence and strategy, chemistry manufacturing and controls (CMC), and non-clinical regulatory
- Participate in departmental initiatives for process improvements and/or regulatory knowledge management
- Obtain valuable foundational knowledge by partaking in the Regulatory Affairs Certification (RAC) course and examination
GSK will recruit qualified post-doctoral Regulatory Affairs fellow candidates to support either:
- Therapeutic Groups (Regulatory Strategy), including oncology
The TG fellow will have the opportunity to:
- Become an integrated member of the cross-functional team and provide regulatory strategic input for both early and late-stage clinical development programs
- Interact with health authorities globally through correspondences and preparation of submission packages to guide product development
- Develop and maintain awareness of the regulatory landscape to inform drug development
- Chemistry Manufacturing Controls (CMC) Biopharmaceuticals
The CMC fellow will have the opportunity to:
- Liaise with health authorities to obtain scientific advice and respond to CMC questions
- Collaborate with a variety of functional areas, such as biopharmaceutical development and supply, manufacturing, device engineering, quality, and clinical, to determine overall CMC regulatory strategy for biopharmaceuticals/cell gene therapy (CGT)
- Plan/prepare CMC Biopharmaceuticals regulatory documents for global submissions across all stages of product development and life cycle
- Support health authority engagements related to scientific advice and CMC questions
The fellowship will also emphasize the development of critical and strategic thinking skills, as well as leadership behaviors.
GlaxoSmithKline is one of the largest global pharmaceutical companies. The company’s mission is to improve the quality of human life by enabling people to do more, feel better, and live longer. GSK produces medicines that treat major disease areas, including asthma, virus control, infections, mental health, diabetes, and digestive conditions. In addition, GSK is a leader in the important area of vaccines and is developing new treatments for cancer. GSK’s Research Triangle Park location comprises nearly 5,000 employees working in state-of-the-art facilities.
Visit http://pharmacydpetfellowships.web.unc.edu/ for instructions on submitting an application.
Application Opens: October 1, 2023
Early Application Deadline: October 31, 2023
Final Application Deadline: November 21, 2023
Robert Dupuis, Pharm.D.
Clinical Professor of Pharmacy and Director of Fellowship Programs
3313 Kerr Hall, CB # 7569