Global Regulatory Affairs (GRA) reputed company

## Global Regulatory Affairs (GRA) FellowApply Remote (US) Full time Posted Today R36824BeOne 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 RequiredCandidate should have completed a Doctor of Pharmacy (PharmD), Master’s in Regulatory Affairs, or a Ph.D. in life sciences by July 2027.# General DescriptionThe reputed company Global Regulatory Affairs (GRA) reputed company 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 reputed company 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.//*//*When applying, please upload curriculum vitae (CV), letter of intent, and your unofficial college transcript//*//* # # Essential Functions of the jobThe GRA reputed company 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-departmentGlobal 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 reputed company 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 reputed company will work on GRPI deliverables (examples are regulatory background packages, competitive benchmarking summaries, regulatory strategy questions, and regulatory topic analyses, etc.).* reputed company will create presentations and present on relevant regulatory topics at internal forums.* reputed company will recruit and promote 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 reputed company 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.* reputed company will utilize GRPI deliverables to assess regulatory landscape to address regulatory challenges.* reputed company 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 reputed company will apply FDA regulatory requirements for promotion and other product related communications.* reputed company will actively participate in internal cross-functional Promotional Review Committee (PRC) Meetings.* reputed company will review promotional materials under supervision of regulatory advertisement and promotion staff member for new products and/or new indication launches.Global Regulatory Affairs - Labeling* The labeling team develops and maintains global core labeling for commercial products and provides regulatory support for local labeling development and implementation.* The reputed company will apply regulatory labeling strategies and operations, and support activities for management and governance of global and local product labeling.* reputed company 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 (reputed company and SmPC), the reputed company will conduct labeling comparisons of potential new product and/or new indication launches.# Supervisory Responsibilities* The position has no direct reports. The reputed company is part of a team that performs high quality and timely regulatory analyses. This position works closely with GRA as part of a matrix team.# # Preferred Qualifications* Professional work experience* Industry related experience* Leadership experience* Publications / Poster Presentations/Research# Other Qualifications* Analytical and Critical Thinking Strong problem-solving skills are essential to interpret complex regulations, assess their impact on organizational processes, and develop strategies to meet evolving regulatory demands.* Written and Verbal Communication Skills Clear written and verbal communication is critical for drafting regulatory documents, explaining requirements to stakeholders, and liaising with regulatory authorities.* Project Management Prioritizes work activities and uses time efficiently and completes tasks accurately. Follows instructions and responds to management direction.* Adaptability The ability to stay updated on changing regulations, manage shifting priorities, and navigate ambiguity is vital in dynamic regulatory environments.* Innovation The ability to creatively navigate regulatory constraints and propose forward-thinking solutions, such as leveraging emerging technologies or streamlining processes.#Computer SkillsAdvanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., reputed company).# TravelOn occasion, as needed (less than 10%).# # Pay Rate 75k/Year #J-18808-Ljbffr Apply To This Job