Global Regulatory Affairs (GRA) Fellow

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Education Required: Candidate should have completed a Doctor of Pharmacy (PharmD) , M aster’s in Regula tory Affairs , or a Ph . D . in life sciences by July 202 7 . General Description: The BeOne Medicines Global Regulatory Affairs (GRA) Fello w will engage in a one-year rotational program that includes working in various departments within GRA to support BeOne regulatory drug development in Global Regulatory Policy and Intelligence (GRPI) , Regulatory Strategy, Advertising and Promotion , and Labeling. The Fellow will apply their scientific knowledge , regulatory learnings and independent judgment to support and execute key deliverables for each sub-function. These key deliverables, presentations and projects inform important regulatory strategy . Effective communication , both written and verbal, and critical thinking are vital skills for this role. The fellowship will be conducted remotely beginning July 202 7 . **When applying, please upload curriculum vitae (CV), letter of intent, and your unofficial college transcript** Essential Functions of the job: The GRA Fellow will rotate throughout the Global Regulatory Affairs Department in the four below sub- departments and perform the tasks identified below under the supervision of each respective sub-department : Global Regulatory Policy and Intelligence (GRPI) The GRPI team analyzes and presents the latest in health authority regulatory trends, policy initiatives, and approvals across therapeutic areas. The fellow will complete timely and thorough analys e s of nuances of regulatory precedents along with tracking dynamic regulatory environment to support BeOne pipeline p roducts . Using critical analysis, problem-solving and writing skills, the f ellow will work on GRPI deliverables ( examples are regulatory background packages, competitive benchmarking summaries, regulatory strategy questions, and regulatory topic analyses, etc .) . Fellow will create presentations and present on relevant regulatory topics at internal forums. Fellow will recruit and promot e for potential future GRA fellowship recruitment cycle during their fellowship year. Global Regulatory Affairs - Strategy The regulatory strategy team plans and coordinates regulatory submissions and provides guidance to the cross-functional development teams on regulatory strategy and tactics. The fellow will partner closely with the regulatory affairs strategy lead(s) by supporting the development and implement ation strategies for optimal regulatory development of BeOne pipeline drug development programs . Fellow will utilize GRPI deliverables to assess regulatory landscape to address regulatory challenges. Fellow may support creation of important communications with health authorities including new INDs, cover letters describing the submission , and support NDAs/BLAs. ​ Global Regulatory Affairs - Advertising and Promotion The regulatory advertising and promotion team administers the promotional review process, prepares FDA submissions for promotional materials, and provides regulatory review and oversight for promotional and non-promotional product communications. The fellow will apply FDA regulatory requirements for promotion and other product related communications. Fellow will actively participate in