Global Regulatory Affairs; GRA) Fellow

Candidate should have completed a Doctor of Pharmacy (PharmD), Master’s in Regulatory Affairs, or a Ph.D. in life sciences by July 2027.

The BeOne Medicines Global Regulatory Affairs (GRA) Fellow 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 2027.

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 analyses of nuances of regulatory precedents along with tracking dynamic regulatory environment to support BeOne pipeline products. Using critical analysis, problem-solving and writing skills, the fellow 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 promote for potential future GRA fellowship recruitment cycle during their fellowship year.

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 implementation 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.

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 internal cross-functional Promotional Review Committee (PRC) Meetings. Fellow will review promotional materials under supervision of regulatory advertisement and promotion staff member for new products and/or new indication launches.

The labeling team develops and maintains global core labeling for commercial products and provides regulatory support for local labeling development and implementation. The fellow will apply regulatory labeling strategies and operations, and support activities for management and governance of global and local product labeling. Fellow will review and assess any developments (i.e., new indications, safety issues) and update/maintain global and local product labeling and Company Core Data Sheet (CCDS).

Analyzing labels (USPI and SmPC), the fellow will conduct…