GlaxoSmithKline Global Regulatory Affairs Fellowship
This global regulatory affairs fellowship is sponsored in collaboration with GlaxoSmithKline
- Early Application Deadline: October 30, 2020
- Application Deadline: December 15, 2020
- 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.
- Apply principles of pharmaceutical product development and 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 that exist within GRA including labeling, advertising and promotion, regulatory intelligence, chemistry manufacturing and controls (CMC), and non-clinical regulatory
- 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
- Chemistry Manufacturing Controls (CMC) Biopharmaceuticals
During the fellowship, the fellow will work with regulatory leaders to gain hands-on experience and have the opportunity to:
- Develop valuable regulatory strategic skills across all phases of drug development and function as an effective project team member
- Prepare regulatory interaction documents and submission packages and interact with regulatory agencies to guide product development
- Develop and maintain awareness of the regulatory landscape to inform drug development
- Participate in departmental initiatives for process improvements and/or regulatory knowledge management
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.
Early Consideration: October 30, 2020
Final: December 15, 2020
After you apply, you will receive a confirmation email once your application has been submitted. Following review, you may be invited to interview at UNC and on-site with fellowship sponsors. You will be notified of the final disposition of your application as soon as possible.
Informational sessions and interviews will be arranged virtually through the IPhO Annual Meeting, the ACCP Annual Meeting, and the ASHP Midyear Clinical Meeting. Potential candidates are encouraged to attend these meetings to meet with UNC faculty, fellows, alumni and sponsors. UNC will also arrange individual virtual interview sessions for selected candidates.
UNC webinars will be held on October 1 and 6, 2020. Registration information coming soon.
Clinical Professor, Pharmacotherapy and Experimental Therapeutics
3201 Kerr Hall, CB# 7569