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 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.  

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 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. 

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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 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. 

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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 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 labeling comparisons of potential new product and/or new indication launches. 

Supervisory Responsibilities:   

• The position has no direct reports. The Fellow 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 Skills: Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva). 

Travel:  

On occasion, as needed (less than 10%).